Dupuytren ContracturePhase 3NCT01776892
Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease
A Phase 3 study testing Collegenase injection and Needle aponeurotomy in people with Dupuytren Contracture, run by University of Alberta at 1 site in Canada.
Trial summary
Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily activities. Treatment traditionally involves cutting out diseased tissue, however this can cause damage to important structures in the hand and results in large scars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Contracture
- What is being tested?
- Collegenase injection and Needle aponeurotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Metacarpophalangeal joint contracture between 20-100 degrees OR proximal interphalangeal joint contracture between 20-80 degrees
- Positive table top test, defined as the inability to simultaneously place the affected finger and palm flat on a table
Who cannot join
- Use of an anticoagulant within 7 days before the beginning of the study, excluding aspirin
- Bleeding disorder
- Recent stroke
- Allergy to collagenase
- A chronic muscular, neurologic, or neuromuscular disorder affecting the hands
- Previous treatment of the affected joint within 90 days before the beginning of the study
Show all 10Show fewer
- Use of a tetracycline derivative within 14 days before the beginning of the study
- Pregnancy
- Breast feeding
- Premenopausal woman, not using contraception
Trial locations and contacts
1 site in 1 country.
About this study
Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily activities. Treatment traditionally involves cutting out diseased tissue, however this can cause damage to important structures in the hand and results in large scars.
Needle aponeurotomy and collagenase injections are newer treatments that are thought to be safer. These treatments allow quicker return to function. One drawback is that Dupuytren's deformity may return more quickly than when all diseased tissue is surgically cut out.
This research study is designed to compare the effectiveness of needle aponeurotomy and collagenase injection for Dupuytren's disease. This study will determine which procedure gives the best results- either needle aponeurotomy, collagenase injection, or both procedures in combination. Participants will be evaluated to see how they do in the long term.
Read the detailed description
Dupuytren's disease is a benign proliferative disorder of the palmar fascia. It results in progressive thickening and contracture of fibrous bands on the volar surface of the palm and fingers as a result of excessive myofibroblast activity. Patients develop longitudinal cords which may lead to progressive joint contractures. Dupuytren's disease limits hand function and can diminish quality of life.
The most commonly used technique for treatment is open limited fasciectomy. The cumulative complication rate ranges from 14-67% and includes nerve division (2-5%), infection (4-12%), neurapraxia (0.4-52%), and regional pain syndrome (2-13%). The recurrence rate of Dupuytren's disease after fasciectomy is approximately 50% at 5 years.
Recently, interest in needle aponeurotomy and collagenase clostridium histolyticum injection have increased as alternative treatment modalities for Dupuytren's disease. Both procedures can be performed in an outpatient clinic, have limited downtime, allow earlier return to work, and are associated with significantly fewer serious complications than open fasciectomy. Needle aponeurotomy and collagenase injection are less invasive than fasciectomy, however they are associated with higher rates of disease recurrence.
Numerous studies investigating the effectiveness and safety of needle aponeurotomy and collagenase injection studies have been published. To date, there is no published literature about the use of these techniques in combination for the treatment of Dupuytren's disease. The investigators propose to follow the patient population of a single surgeon performing needle aponeurotomy in combination with collagenase injection to determine the effectiveness of this combination treatment. Patients treated with combination treatment will be compared to patients treated with a single modality- either needle aponeurotomy or collagenase injection.
Patients will be assessed pre and post operatively to evaluate functional status and the degree of joint contracture. Patient satisfaction, adverse events, recurrence, and repeat treatment rates will also be determined.
- Conditions
- Dupuytren Contracture
- Being tested
- Collegenase injection, Needle aponeurotomy
- Keywords
- Collagenase, Needle aponeurotomy
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collegenase injectionDrug
Also called Trade name: Xiaflex.
Collagenase clostridium histolyticum will be used to treat participants in this arm of the study. Affected cords will be treated with 1-3 collagenase injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections.
Metacarpophalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.25ml of sterile diluent. Proximal interphalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.20ml of sterile diluent.
Needle aponeurotomyProcedure or surgery
Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained.
| Study group | Role | What they receive |
|---|---|---|
| Collagenase and needle aponeurotomy | Experimental | Participants in this arm of the study will be treated once with needle aponeurotomy and up to 3 times at 4 week intervals with collagenase injection.
Affected Dupuytren's cords will be treated with 1-3 collagenase clostridium histolyticum injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections.
Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained. Receives: Drug: Collegenase injection; Procedure: Needle aponeurotomy |
| Needle aponeurotomy | Active comparator | Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained. Participant feedback is obtained throughout the procedure to prevent digital nerve or flexor tendon injury. Participants are asked to report Tinel's sign which indicates that the needle is in close proximity to the digital nerve and to report pain with needle advancement which indicates proximity to the flexor tendon. Receives: Procedure: Needle aponeurotomy |
| Collagenase injection | Active comparator | Collagenase clostridium histolyticum will be used to treat participants in this arm of the study. Affected cords will be treated with 1-3 collagenase injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections. Metacarpophalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.25ml of sterile diluent. Proximal interphalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.20ml of sterile diluent. Receives: Drug: Collegenase injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of joint contracture post treatment
The degree of the participant's Dupuytren's disease joint contracture after treatment will be measured by a physical therapist at each of the participant's follow up appointments.
Measured: 5 years post treatment
Secondary outcomes (1)
Change in joint range of motion
The participant's range of motion in their joint affected by Dupuytren's disease will be measured by a physical therapist prior to treatment and following treatment at each of the participant's follow up appointments.
Measured: Baseline and 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Morhart, MD MSc, Principal investigator, Division of Plastic Surgery, Department of Surgery, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776892
- Sponsor's protocol ID
- Dupuytren's 001
- Status last verified
- Apr 2014
- First submitted
- 17 Jan 2013
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Badalamente MA, Hurst LC. Enzyme injection as nonsurgical treatment of Dupuytren's disease. J Hand Surg Am. 2000 Jul;25(4):629-36. doi: 10.1053/jhsu.2000.6918.
PubMed 10913202Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: nonoperative treatment of Dupuytren's disease. J Hand Surg Am. 2002 Sep;27(5):788-98. doi: 10.1053/jhsu.2002.35299.
PubMed 12239666Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.
PubMed 19726771Gilpin D, Coleman S, Hall S, Houston A, Karrasch J, Jones N. Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren's disease. J Hand Surg Am. 2010 Dec;35(12):2027-38.e1. doi: 10.1016/j.jhsa.2010.08.007.
PubMed 21134613van Rijssen AL, Ter Linden H, Werker PMN. Five-year results of a randomized clinical trial on treatment in Dupuytren's disease: percutaneous needle fasciotomy versus limited fasciectomy. Plast Reconstr Surg. 2012 Feb;129(2):469-477. doi: 10.1097/PRS.0b013e31823aea95.
PubMed 21987045
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease
- ClinicalTrials.gov ID
- NCT01776892
- Acronym / sponsor ID
- Dupuytren's 001
- Conditions
- Dupuytren Contracture
- Keywords
- Collagenase, Needle aponeurotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily activities. Treatment traditionally involves cutting out diseased tissue, however this can cause damage to important structures in the hand and results in large scars.
Needle aponeurotomy and collagenase injections are newer treatments that are thought to be safer. These treatments allow quicker return to function. One drawback is that Dupuytren's deformity may return more quickly than when all diseased tissue is surgically cut out.
This research study is designed to compare the effectiveness of needle aponeurotomy and collagenase injection for Dupuytren's disease. This study will determine which procedure gives the best results- either needle aponeurotomy, collagenase injection, or both procedures in combination. Participants will be evaluated to see how they do in the long term.
Detailed description
Dupuytren's disease is a benign proliferative disorder of the palmar fascia. It results in progressive thickening and contracture of fibrous bands on the volar surface of the palm and fingers as a result of excessive myofibroblast activity. Patients develop longitudinal cords which may lead to progressive joint contractures. Dupuytren's disease limits hand function and can diminish quality of life.
The most commonly used technique for treatment is open limited fasciectomy. The cumulative complication rate ranges from 14-67% and includes nerve division (2-5%), infection (4-12%), neurapraxia (0.4-52%), and regional pain syndrome (2-13%). The recurrence rate of Dupuytren's disease after fasciectomy is approximately 50% at 5 years.
Recently, interest in needle aponeurotomy and collagenase clostridium histolyticum injection have increased as alternative treatment modalities for Dupuytren's disease. Both procedures can be performed in an outpatient clinic, have limited downtime, allow earlier return to work, and are associated with significantly fewer serious complications than open fasciectomy. Needle aponeurotomy and collagenase injection are less invasive than fasciectomy, however they are associated with higher rates of disease recurrence.
Numerous studies investigating the effectiveness and safety of needle aponeurotomy and collagenase injection studies have been published. To date, there is no published literature about the use of these techniques in combination for the treatment of Dupuytren's disease. The investigators propose to follow the patient population of a single surgeon performing needle aponeurotomy in combination with collagenase injection to determine the effectiveness of this combination treatment. Patients treated with combination treatment will be compared to patients treated with a single modality- either needle aponeurotomy or collagenase injection.
Patients will be assessed pre and post operatively to evaluate functional status and the degree of joint contracture. Patient satisfaction, adverse events, recurrence, and repeat treatment rates will also be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Collagenase and needle aponeurotomy | Experimental | Drug: Collegenase injection, Procedure: Needle aponeurotomyParticipants in this arm of the study will be treated once with needle aponeurotomy and up to 3 times at 4 week intervals with collagenase injection. Affected Dupuytren's cords will be treated with 1-3 collagenase clostridium histolyticum injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections. Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained. |
| Needle aponeurotomy | Active comparator | Procedure: Needle aponeurotomyPercutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained. Participant feedback is obtained throughout the procedure to prevent digital nerve or flexor tendon injury. Participants are asked to report Tinel's sign which indicates that the needle is in close proximity to the digital nerve and to report pain with needle advancement which indicates proximity to the flexor tendon. |
| Collagenase injection | Active comparator | Drug: Collegenase injectionCollagenase clostridium histolyticum will be used to treat participants in this arm of the study. Affected cords will be treated with 1-3 collagenase injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections. Metacarpophalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.25ml of sterile diluent. Proximal interphalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.20ml of sterile diluent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Metacarpophalangeal joint contracture between 20-100 degrees OR proximal interphalangeal joint contracture between 20-80 degrees
- Positive table top test, defined as the inability to simultaneously place the affected finger and palm flat on a table
Key exclusion criteria (10 listed)
- Use of an anticoagulant within 7 days before the beginning of the study, excluding aspirin
- Bleeding disorder
- Recent stroke
- Allergy to collagenase
- A chronic muscular, neurologic, or neuromuscular disorder affecting the hands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collegenase injectionAlso: Trade name: Xiaflex.Collagenase clostridium histolyticum will be used to treat participants in this arm of the study. Affected cords will be treated with 1-3 collagenase injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections. Metacarpophalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.25ml of sterile diluent. Proximal interphalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.20ml of sterile diluent. | Drug | Collagenase and needle aponeurotomy, Collagenase injection |
| Needle aponeurotomyPercutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained. | Procedure or surgery | Collagenase and needle aponeurotomy, Needle aponeurotomy |
Primary outcome
Degree of joint contracture post treatment
Time frame: 5 years post treatment
The degree of the participant's Dupuytren's disease joint contracture after treatment will be measured by a physical therapist at each of the participant's follow up appointments.
1 secondary outcome
Change in joint range of motion
Time frame: Baseline and 5 years post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Background: PubMed 10913202Badalamente MA, Hurst LC. Enzyme injection as nonsurgical treatment of Dupuytren's disease. J Hand Surg Am. 2000 Jul;25(4):629-36. doi: 10.1053/jhsu.2000.6918.
- Background: PubMed 12239666Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: nonoperative treatment of Dupuytren's disease. J Hand Surg Am. 2002 Sep;27(5):788-98. doi: 10.1053/jhsu.2002.35299.
- Background: PubMed 19726771Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.
- Background: PubMed 21134613Gilpin D, Coleman S, Hall S, Houston A, Karrasch J, Jones N. Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren's disease. J Hand Surg Am. 2010 Dec;35(12):2027-38.e1. doi: 10.1016/j.jhsa.2010.08.007.
- Background: PubMed 21987045van Rijssen AL, Ter Linden H, Werker PMN. Five-year results of a randomized clinical trial on treatment in Dupuytren's disease: percutaneous needle fasciotomy versus limited fasciectomy. Plast Reconstr Surg. 2012 Feb;129(2):469-477. doi: 10.1097/PRS.0b013e31823aea95.
Related trials for Dupuytren Contracture
Not yet recruiting
Kinesitherapy Plus Osteopathy After Surgery for Dupuytren Disease
Dupuytren Disease
Not yet recruitingPhase 3
DEPART Study at Yale
Dupuytren's Contracture
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Recruiting
Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
Dupuytren Contracture
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Morhart, MD MSc principal investigator
Division of Plastic Surgery, Department of Surgery, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collegenase injection and Needle aponeurotomy in people with Dupuytren Contracture, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of joint contracture post treatment (time frame: 5 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01776892, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.