Collagenase Clostridium Histolyticum (Xiaflex)

Number: 1061

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

---

Policy

Scope of Policy

This Clinical Policy Bulletin addresses collagenase clostridium histolyticum (Xiaflex) for commercial medical plans. 

1. Exclusions 

   Collagenase clostridium histolyticum (Xiaflex) is not covered for cosmetic use (e.g., cellulite reduction treatment).

2. Prescriber Specialties

   1. Dupuytren's contracture: The medication must be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture.
   2. Peyronie's disease: The medication must be administered by a healthcare provider experienced in the treatment of urological disease and who has completed the Xiaflex REMS program requirements.

3. Criteria for Initial Approval

   Aetna considers collagenase clostridium histolyticum (Xiaflex) medically necessary for the following indications when criteria are met:

   1. Dupuytren's contracture treatment when all the following criteria are met:

      1. The member has a finger flexion contracture with a palpable cord in a metacarpophalangeal joint or a proximal interphalangeal joint prior to initiating Xiaflex therapy; and
      2. The contracture is at least 20 degrees prior to initiating Xiaflex therapy; and
      3. The member had a positive tabletop test, defined as the inability to simultaneously place the affected finger(s) and palm flat against a table prior to initiating Xiaflex therapy; and
      4. The member is 18 years of age or older; and
      5. The member will receive up to 3 injections maximum per cord (4 weeks apart) as part of the current treatment;

   2. Peyronie's disease treatment when all of the following criteria are met:

      1. The member has stable Peyronie's disease without clinical changes (e.g., worsening curvature) for at least three months; and
      2. The member has a palpable plaque and curvature deformity of at least 30 degrees and less than 90 degrees prior to initiating Xiaflex therapy; and
      3. The member has intact erectile function (with or without medication); and
      4. The member is 18 years of age or older; and
      5. The member will receive a maximum of one treatment course with a maximum of 8 injections total, including any injections the member has received for any previous treatment.

   Aetna considers all other indications as experimental, investigational, or unproven.

4. Continuation of Therapy

   Aetna considers continuation of collagenase clostridium histolyticum (Xiaflex) therapy medically necessary for the following indications when criteria are met:

   1. Dupuytren's contracture treatment when all of the following are met:

      1. The member meets all initial authorization criteria; and
      2. The member is continuing with a treatment course for the same cord. For treatment of a new cord or a previously treated cord following recurrence, member must meet all initial authorization criteria; and
      3. The member has received less than 3 injections total per cord (4 weeks apart);

   2. Peyronie's disease treatment when all of the following criteria are met:

      1. The member meets all initial authorization criteria; and
      2. The member has curvature deformity of at least 15 degrees at the time of the continuation request; and
      3. The member has received less than 8 injections total, including any injections the member has received for any previous treatment. 

5. Related Policies 

   1. CPB 0007 - Erectile Dysfunction
   2. CPB 0800 - Dupuytren's Contracture Treatments

Dosage and Administration

Xiaflex is supplied in single-use glass vials containing 0.9 mg of collagenase clostridium histolyticum as a sterile, lyophilized powder for reconstitution, for intralesional use. Sterile diluent for reconstitution is provided in the package in a single-use glass vial containing 3 mL of 0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride. Below includes dosing recommendations as per the FDA-approved prescribing information.

Dupuytren's Contracture

• Xiaflex should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture.
• Xiaflex  must be reconstituted with the provided diluent prior to use.
• The recommended dose of Xiaflex is 0.58 mg per injection into a palpable Dupuytren's cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint according to the injection procedure.
• Each vial of Xiaflex and sterile diluent should only be used for a single injection. If two joints on the same hand are to be treated during a treatment visit, separate vials and syringes should be used for each reconstitution and injection.
• Up to two joints in the same hand may be treated during a treatment visit.
• Approximately 24 to 72 hours following an injection, finger extension procedure is performed if a contracture persists.
• Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.
• Inject up to two cords in the same hand at a treatment visit.  Two palpable cords affecting two joints may be injected or one palpable cord affecting two joints in the same finger may be injected at two locations during a treatment visit. If individual has other palpable cords with contractures of MP or PIP joints, these cords may be injected with Xiaflex at other treatment visits approximately 4 weeks apart. 

Peyronie's Disease

• Xiaflex should be administered by a healthcare provider experienced in the treatment of male urological diseases, who has completed required training for use of Xiaflex in the treatment of
  Peyronie's disease.
• Xiaflex must be reconstituted with the provided diluent prior to use.
• The dose of Xiaflex is 0.58 mg per injection administered into a Peyronie's plaque. If more than one plaque is present, inject into the plaque causing the curvature deformity.
• A treatment course consists of a maximum of 4 treatment cycles.
• Each treatment cycle consists of two Xiaflex injection procedures and one penile modeling procedure.
• The second Xiaflex injection procedure is performed 1 to 3 days after the first.
• The penile modeling procedure is performed 1 to 3 days after the second injection of the treatment cycle.
• The interval between treatment cycles is approximately 6 weeks. The treatment course therefore, consists of a maximum of 8 injection procedures and 4 modeling procedures.
• If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if the healthcare provider determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered.
• The safety of more than one treatment course of Xiaflex is not known.

Source: Endo Pharmaceuticals, 2022

Experimental, Investigational, or Unproven

Aetna considers the following interventions experimental, investigational, or unproven (not an all-inclusive list):

• Ultrasound guidance for injection of Xiaflex in the management of Dupuytren's contracture
• Hand therapy after collagenase treatment for Dupuytren's contracture (Note: Finger extension procedures may be necessary following collagenase injections if Dupuytren's contractures persist; see Dosing and Administration).

---

Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Other CPT codes related to the CPB:
20550	Injection(s); single tendon sheath, or ligament, aponeurosis (eg, plantar "fascia")
96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
HCPCS codes covered if selection criteria are met:
J0775	Injection, collagenase clostridium histolyticum, 0.01 mg [not for cosmetic use
ICD-10 codes covered if selection criteria are met:
M72.0	Palmar fascial fibromatosis
N48.6	Induration of penis plastica

---

Background

U.S. Food and Drug Administration (FDA)-Approved Indications 

• Xiaflex is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord.
• Xiaflex is indicated for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.  

Collagenase clostridium histolyticum is branded as Xiaflex (Endo Pharmaceuticals, Inc.). Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. Xiaflex is an intralesional injection that has been FDA-approved for treatment of Dupuytren's contracture and Peyronie's disease.

Xiaflex is contraindicated in Peyronie’s plaques that involve the penile urethra. 

Xiaflex carries a boxed warning for corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie's disease. Corporal rupture was reported as an adverse reaction in 5 of 1044 (0.5%) Xiaflex-treated patients in clinical studies. In other Xiaflex-treated patients (9 of 1044; 0.9%), a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) Xiaflex-treated patients. Xiaflex is available for the treatment of Peyronie’s disease only through a restricted program called the XIAFLEX REMS Program. 

Labeled warnings and precautions also include the following:

• Tendon rupture or serious injury to the injected finger/hand
• Hypersensitivity reactions, including anaphylaxis
• Patients with abnormal coagulation: Use with caution, including in patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection
• Acute post-injection back pain reactions
• Syncope and presyncope, as post-injection pain can trigger syncope and presyncope.

The most common adverse reactions include the following:

• Dupuytren's contracture: reported in 25% or more of patients treated with Xiaflex and at an incidence greater than placebo were edema peripheral (e.g., swelling of the injected hand), contusion, injection site hemorrhage, injection site reaction, and pain in the injected extremity;
• Peyronie's disease: reactions reported with 25% or more of patients treated with Xiaflex and at an incidence greater than placebo were penile hematoma, penile swelling and penile pain.

Dupuytren's Contracture

Dupuytren's contracture is characterized by progressive fibrosis of the palmar fascia, or abnormal thickening of the skin in the palm of the hand at the finger base, which can result in a hard lump or thick band. Over time, it can cause one or more fingers to contract, which may be painful. Injection of collagenase clostridium histolyticum (Xiaflex, Endo Pharmaceuticals, Inc.) into a Dupuytren’s cord, which is comprised mostly of collagen, may result in enzymatic disruption of the cord. For additional information, see CPB 0800 - Dupuytren's Contracture Treatments.

Swartz and Lalonde (2008) stated that treatment of Dupuytren's disease is offered to symptomatic patients with painful nodular or disabling contracture.  Limited fasciectomy of the involved abnormal structures followed by hand therapy is standard treatment, but it is associated with serious potential complications.  Moreover, recurrence is common.  New treatments include the injection of clostridial collagenase, which works by breaking down the excessive build-up of collagen in the hand.

In a phase II open-label clinical trial, Badalamente and Hurst (2000) examined the clinical safety and effectiveness of clostridial collagenase injection as a non-surgical treatment of Dupuytren's disease.  A total of 35 patients entered the study (3 women and 32 men).  The mean age was 65 years.  The first 6 patients were treated following a dose escalation protocol and received 300, 600, 1,200, 2,400, 4,800, and 9,600 units (U) collagenase injected into the cord that was causing contracture of the MCP joint.  There were no beneficial clinical effects of these injections.  The remaining 29 patients had collagenase injections at a dose level of 10,000 U into cords that are causing contractures of 34 MCP joints, 9 PIP joints, and 1 thumb.  Twenty-eight of the 34 MCP joint contractures corrected to normal extension (0 degrees) and 2 of the 34 MCP joint contractures corrected to 5 degrees of normal extension, with full range of motion, within 1 to 14 days of injection.  In patients with PIP joint contractures, 4 of the 9 joints corrected to normal (0 degrees).  One PIP joint corrected to within 10 degrees of normal and 2 corrected to within 15 degrees of normal.  There were 2 failures; these patients required surgery.  The mean follow-up period was 20.0 +/- 5.6 months for the MCP joints and 14.1 +/- 6.6 months for the PIP joints.  Clostridial collagenase injection of Dupuytren's cords causing MCP and PIP joint contractures appears to have merit as non-surgical treatment of this disorder.  The authors stated that pending further placebo, double-blind studies, collagenase injection to treat Dupuytren's disease may be a safe and effective alternative to surgical fasciectomy.

Badalamente et al (2002) reported that in a series of controlled phase II clinical trials, excessive collagen deposition in Dupuytren's disease has been targeted by a unique non-operative method using clostridial collagenase injection therapy to lyse and rupture finger cords causing MCP and/or PIP joint contractures.  A total of 49 patients were treated in a random, placebo-controlled trial of one dose of collagenase versus placebo at 1 center.  Subsequently 80 patients were treated in a random, placebo-controlled, dose-response study of collagenase at 2 test centers.  The results of these studies indicated that non-operative collagenase injection therapy for Dupuytren's disease is both a safe and effective method of treating this disorder in the majority of patients as an alternative to surgical fasciectomy.

In a prospective, randomized, double-blind, placebo-controlled, multi-center study, Hurst et al (2009) examined the effects of injectable collagenase clostridium histolyticum for the treatment of Dupuytren's contracture.  These investigators enrolled 308 patients with joint contractures of 20 degrees or more .  The primary MCP or PIP joints of these patients were randomly assigned to receive up to 3 injections of collagenase clostridium histolyticum (at a dose of 0.58 mg per injection) or placebo in the contracted collagen cord at 30-day intervals.  One day after injection, the joints were manipulated. The primary end point was a reduction in contracture to 0 to 5 degrees of full extension 30 days after the last injection.  Twenty-six secondary end points were evaluated, and data on adverse events were collected.  Collagenase treatment significantly improved outcomes.  More cords that were injected with collagenase than cords injected with placebo met the primary end point (64.0 % versus 6.8 %, p < 0.001), as well as all secondary end points (p < or = 0.002).  Overall, the range of motion in the joints was significantly improved after injection with collagenase as compared with placebo (from 43.9 to 80.7 degrees versus from 45.3 to 49.5 degrees, p < 0.001).  The most commonly reported adverse events were localized swelling, pain, bruising, pruritus, and transient regional lymph-node enlargement and tenderness.  Three treatment-related serious adverse events were reported: 2 tendon ruptures and 1 case of complex regional pain syndrome.  No significant changes in flexion or grip strength, no systemic allergic reactions, and no nerve injuries were observed.  The authors concluded that collagenase clostridium histolyticum injection significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren's disease.

On February 2, 2010, the Food and Drug Administration approved collagenase clostridium histolyticum (Xiaflex) as the first drug to treat Dupuytren's contracture.  Xiaflex is injected directly into the collagen cord of the hand and should be administered only by a health care professional experienced with injections of the hand, because tendon ruptures may occur.  The product insert of Xiaflex states that injections may be administered up to 3 times per cord at approximately 4-week intervals.  Up to two cords may be injected at a time.  If patients have other cords with contractures of MCP or PIP joints, these cords should be injected in sequential order.

In the controlled portions of the clinical trials in Dupuytren’s contracture (Studies 1 and 2), a greater proportion of Xiaflex-treated patients (15%) compared to placebo-treated patients (1%) had mild allergic reactions (pruritus) after up to 3 injections. The incidence of Xiaflex-associated pruritus increased after more Xiaflex injections in patients with Dupuytren’s contracture. 

Peimer et al (2013) evaluated long-term safety and effectiveness of collagenase clostridium histolyticum-injection (CCH) after the 3rd year of a 5-year non-treatment follow-up study (Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study [CORDLESS study]).  This study enrolled DC patients from 5 previous clinical studies.  Beginning 2 years after the 1st CCH injection, these investigators re-evaluated patients annually for joint contracture and safety.  Recurrence in a previously successfully treated joint (success = 0° to 5° contracture after CCH administration) was defined as 20° or greater worsening in contracture in the presence of a palpable cord or medical/surgical intervention to correct new or worsening contracture. We assessed partially corrected joints (joints reduced 20° or more from baseline contracture but not to 0° to 5°) for nondurable response, also defined as 20° or greater worsening of contracture or medical/surgical intervention.  Of 1,080 CCH-treated joints (648 MCP; 432 PIP; n = 643 patients), 623 (451 MCP, 172 PIP) had achieved 0° to 5° contracture in the original study.  Of these joints, 35 % (217 of 623) recurred (MCP 27 %; PIP 56 %).  Of these recurrences, an intervention was performed in 7 %.  Of the 1,080 CCH-treated joints, 301 were partially corrected in the original study.  Of these, 50 % (150 of 301; MCP: 38 % [57 of 152]; PIP: 62 % [93 of 149]) had non-durable response.  These researchers identified no new long-term or serious adverse events attributed to CCH during follow-up.  Anti-clostridial type I collagenase and/or anti-clostridial type II collagenase antibodies were reported for 96 % or more of patients who received 2 or more CCH injections and 82 % who received 1 injection.  The authors concluded that recurrence rate, which is comparable to other standard treatments, and the absence of long-term adverse events 3 years after initial treatment indicated that CCH is safe and effective treatment for DC.  Most successfully treated joints had a contracture well below the threshold for surgical intervention 3 years after treatment.  Recurrence rates among successfully treated joints were lower than non-durable response rates among partially corrected joints.

Peyronie's Disease

Peyronie's disease (PD) is an acquired condition in which plaques (segments of flat scar tissue) form under the skin of the penis resulting in penile deformity. This condition may cause pain, and in some men, erectile dysfunction (ED). For information on ED treatments, see CPB 0007 - Erectile Dysfunction.

The signs and symptoms of Peyronie’s disease have been found to be caused by a collagen plaque. Injection of collagenase clostridium histolyticum into a Peyronie’s plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque. Following this disruption of the plaque, penile curvature deformity caused by Peyronie's disease are reduced.   

Jordan (2008) evaluated the safety and effectiveness of intralesional clostridial collagenase injection therapy in a series of patients with Peyronie's disease.  A total of 25 patients aged 21 to 75 years who were referred to a single institution with a well-defined Peyronie's disease plaque were treated with three intralesional injections of clostridial collagenase 10,000 units in a small volume (0.25 cm(3) per injection) administered over 7 to 10 days, with a repeat treatment (i.e., 3 injections of collagenase 10,000 units/25 cm(3) injection over 7 to 10 days) at 3 months.  Primary efficacy measures were changes from baseline in the deviation angle and plaque size.  Secondary efficacy end-points were patient responses to a Peyronie's disease questionnaire and improvement according to the investigators' global evaluation of change.  The primary efficacy measures were change in deviation angle and change in plaque size.  Secondary end-points were patient questionnaire responses and improvement according to the investigators' global evaluation of change.  Significant decreases from baseline were achieved in the mean deviation angle at months 3 (p = 0.0001) and 6 (p = 0.0012), plaque width at months 3 (p = 0.0052), 6 (p = 0.0239), and 9 (p = 0.0484), and plaque length at months 3 (p = 0.0018) and 6 (p = 0.0483).  More than 50 % of patients in this series considered themselves "very much improved" or "much improved" at all time-points in the study, and the drug was generally well-tolerated.  The authors concluded that the benefits of intralesional clostridial collagenase injections in this trial lent support to prior studies supporting its use in the management of Peyronie's disease.  Moreover, they noted that a double-blind, placebo-controlled study is currently under development.

In a phase IIb, double-blind, randomized, placebo-controlled study, Gelbard and colleagues (2012) examined the safety and effectiveness of collagenase Clostridium histolyticum and assessed a patient reported outcome questionnaire.  A total of 147 subjects were randomized into 4 groups to receive collagenase C. histolyticum or placebo (3:1) with or without penile plaque modeling (1:1).  Per treatment cycle 2 injections of collagenase C. histolyticum (0.58 mg) were given 24 to 72 hours apart.  Subjects received up to 3 cycles at 6-week intervals.  When designated, investigator modeling was done 24 to 72 hours after the second injection of each cycle.  These researchers evaluated penile curvature by goniometer measurement, patient reported outcomes and adverse event profiles.  After collagenase C. histolyticum treatment significant improvements in penile curvature (29.7 % versus 11.0 %, p = 0.001) and patient reported outcome symptom bother scores (p = 0.05) were observed compared to placebo.  In modeled subjects 32.4 % improvement in penile curvature was observed in those on collagenase C. histolyticum compared to 2.5 % worsening of curvature in those on placebo (p < 0.001).  Those treated with collagenase C. histolyticum who underwent modeling also showed improved Peyronie disease symptom bother scores (p = 0.004).  In subjects without modeling there were minimal differences between the active and placebo cohorts.  Most adverse events in the collagenase C. histolyticum group occurred at the injection site and were mild or moderate in severity.  No treatment related serious adverse events were reported.  The authors concluded that collagenase C. histolyticum treatment was well-tolerated.  Moreover, they noted significant improvement in penile curvature and patient reported outcome symptom bother scores, suggesting that this may be a safe, non-surgical alternative for Peyronie disease.

Gelbard et al (2013) stated that IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II examined the clinical safety and effectiveness of collagenase C. histolyticum intra-lesional injections in subjects with Peyronie disease.  Co-primary outcomes in these identical phase III randomized, double-blind, placebo controlled studies included the percent change in the penile curvature abnormality and the change in the Peyronie disease questionnaire symptom bother score from baseline to 52 weeks.  IMPRESS I and II examined collagenase C. histolyticum intralesional injections in 417 and 415 subjects, respectively, through a maximum of 4 treatment cycles, each separated by 6 weeks.  Men received up to 8 injections of 0.58 mg collagenase C. histolyticum that are 2 injections per cycle separated by approximately 24 to 72 hours with the second injection of each followed 24 to 72 hours later by penile plaque modeling.  Men were stratified by baseline penile curvature (30 to 60 versus 61 to 90 degrees) and randomized to collagenase C. histolyticum or placebo 2:1 in favor of the former.  Post hoc meta-analysis of IMPRESS I and II data revealed that men treated with collagenase C. histolyticum showed a mean 34 % improvement in penile curvature, representing a mean ± SD -17.0 ± 14.8 degree change per subject, compared with a mean 18.2 % improvement in placebo treated men, representing a mean -9.3 ± 13.6 degree change per subject (p <0.0001).  The mean change in Peyronie disease symptom bother score was significantly improved in treated men versus men on placebo (-2.8 ± 3.8 versus -1.8 ± 3.5, p = 0.0037).  Three serious adverse events (corporeal rupture) were surgically repaired.  The authors concluded that IMPRESS I and II supported the clinical safety and effectiveness of collagenase C. histolyticum for the physical and psychological aspects of Peyronie disease.

On December 6, 2013, the FDA approved Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine for the treatment of Peyronie’s disease.  A treatment course for Peyronie’s disease consists of a maximum of 4 treatment cycles.  Each treatment cycle consists of 2 Xiaflex injection procedures (in which Xiaflex is injected directly into the collagen-containing structure of the penis) and 1 penile modeling procedure performed by the health care professional.  The safety and effectiveness of Xiaflex for the treatment of Peyronie’s disease were established in 2 randomized double-blind, placebo-controlled studies in 832 men with Peyronie’s disease with penile curvature deformity of at least 30 degrees.  Participants were given up to 4 treatment cycles of Xiaflex or placebo and were then followed 52 weeks.  Xiaflex treatment significantly reduced penile curvature deformity and related bothersome effects compared with placebo.  The most common adverse reactions associated with use of Xiaflex for Peyronie’s disease include penile hematoma, penile swelling and penile pain.

According to the FDA, when prescribed for the treatment of Peyronie’s disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) because of the risks of serious adverse reactions, including penile fracture (rupture of one of the penile bodies within the penile shaft, also known as corporal rupture) and other serious penile injury.  Xiaflex for the treatment of Peyronie’s disease should be administered by a health care professional who is experienced in the treatment of male urological diseases. The REMS requires participating health care professionals to be certified within the program by enrolling and completing training in the administration of Xiaflex treatment for Peyronie’s disease.  The REMS also requires health care facilities to be certified within the program and ensure that Xiaflex is dispensed only for use by certified health care professionals. The most frequently reported adverse drug reactions (25% or more) of patients treated with Xiaflex and at an incidence greater than placebo were penile hematoma, penile swelling, and penile pain.

Hand Therapy After Collagenase Treatment for Dupuytren's Contracture

Aglen and colleagues (2019) stated that Dupuytren's contracture (DC) is a fibrotic hand condition in which 1 or more fingers develop progressive flexion deformities.  Quality of life (QOL) is diminished due to disabling limitations in performing everyday activities.  For DC patients treated with collagenase, referral for subsequent hand therapy is inconsistent.  It is unclear if subsequent hand therapy is beneficial compared to no therapy.  The purpose of this study is to examine if hand therapy improves DC patients' performance of and satisfaction with performing everyday activities 1 year after collagenase treatment.  These researchers will carry out a RCT with 2 treatment groups (hand therapy versus control) of DC patients who have received collagenase treatment.  DC patients with contracted MCP (hand therapy, n = 40; control, n = 40) and those with PIP involvement (hand therapy, n = 40; control, n = 40) comprise 2 subgroups, and these investigators will study if the treatment effect will be different between both groups (n = 160).  Patients with a previous injury or treatment for DC in the treatment finger are excluded.  Hand therapy includes edema and scar management, splinting, movement exercises, and practice of everyday activities.  The main outcome variable is patients' performance of and satisfaction with performing everyday activities, as assessed with the Canadian Occupational Performance Measure.  Secondary outcomes are DC-specific activity problems, as assessed with the Unité Rhumatologique des Affections de la Main scale, and active/passive flexion/extension of treated joints and grip force using standard measuring tools, and self-reported pain level.  Demographic and clinical variables, degree of scarring, cold hypersensitivity, number of occupational sick-leave days are collected.  Self-reported global impression of change will be used to assess patient satisfaction with change in hand function.  Assessments are performed pre-injection and 6 weeks, 4 months, and 1 year later.  Standard uni-variate and multi-variate statistical analyses will be used to evaluate group differences.  The authors concluded that this study aims to examine if hand therapy is beneficial for activity-related, biomechanical, and clinical outcomes in DC patients after collagenase treatment.  The results will provide an objective basis for determining whether hand therapy should be conducted after collagenase treatment.

Ultrasound Guidance for Injection of Xiaflex

In a prospective, cohort study, Aguilella and colleagues (2022) compared the effectiveness of ultrasound (US)-guided injection of CCH in patients with Dupuytren's contracture (DC), with the standard injection.  These researchers hypothesized that US-guided Injection of CCH is more effective than the standard injection.  These investigators treated consecutively 47 fingers with the standard injection and 43 with the US-guided injection.  Patients in both groups had the same inclusion criteria.  The degrees of contracture of the MCP and PIP joints were measured before treatment and after 3 months.  They compared the effectiveness of each type of injection with respect to obtaining a complete finger extension and to the percentage of improvement in each finger and in each joint.  With US-guided injection, complete finger extension was obtained in 54% of cases and an 81% mean percentage of correction of the finger contracture; with standard injection 49% and 77%, respectively.  In the MCP joint, the mean percentage of correction was 92.5% in the US-guided Injection group and 84% in the standard injection group.  In the PIP joint, it was 75.1 % in the US-guided injection group and 65.3% in the standard injection group.  The authors concluded that these findings showed no statistical significance; these researchers stated that hand surgeons must balance the possible benefits of the US-guided injection with the complexity and resources needed to perform the technique.

---

References