search
Back to results

Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease

Primary Purpose

Dupuytren Contracture, Dupuytren's Disease of Finger

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Percutaneous Needle Aponeurotomy
XIAFLEX
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dupuytren Contracture focused on measuring Collagenase injection, percutaneous needle aponeurotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients requiring treatment for functionally limiting Dupuytren's disease involving the MCP and PIP joints, defined as MCP joint contracture 20-100 degrees, PIP joint contracture 20-80 degrees and positive table top test. Patients must be over 18 years of age to enroll in the study.

Exclusion Criteria:

  • Patients who have had previous interventions of contracture presenting for treatment, in an effort to compare similar disease state and risk with each procedure.
  • Disease involving DIP joint or thumb, as collagenase has not been approved for use in the thumb or DIP joints.
  • Pregnant or nursing, although there is data indicating no detection of collagenase in patient serum following injection for Dupuytren's contractures, there is no data exploring the effects of collagenase on a fetus or infant.
  • Anticoagulation therapy other than ASA (held 7 days prior to procedure), which is a recommendation by the manufacture of collagenase used in this study.

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Percutaneous Needle Aponeurotomy

Collagenase Injection

Arm Description

Percutaneous Needle Aponeurotomy (PNA) involves the surgeon anaesthetizing the skin over the Dupuytren's cord, then using a small gauge needle inserted percutaneously, cutting the cord with the sharp edge of the needle using a sweeping motion. This is repeated up the length of the cord to weaken it, allowing an extension force to be applied over the finger to rupture the cord.

Collagenase Injection (CI) involves the injection of collagenase clostridium histolyticum (0.58 mg), directly into the Dupuytren's cord. The patient then returns to see the surgeon within one week, has local anaesthetic is administered, and an extension force is applied to the affected digit to rupture the already weakened cord.

Outcomes

Primary Outcome Measures

Contracture Recurrence
Recurrence defined by an increase in joint contracture of at least 30 degrees in presence of palpable cord, or the patient underwent repeat intervention to correct new/worsening contracture in the treated joint.

Secondary Outcome Measures

Patient Satisfaction
Survey
Complications
Patient to Report

Full Information

First Posted
December 17, 2016
Last Updated
December 20, 2016
Sponsor
University of Calgary
search

1. Study Identification

Unique Protocol Identification Number
NCT03000114
Brief Title
Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease
Official Title
Comparison of Collagenase Injection and Percutaneous Needle Aponeurotomy for Treatment of Dupuytren's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Dupuytren's disease is a non-curative, progressive disorder leading to function-impairing deformities of the hand. Although numerous treatments exist, the most common and widely accepted therapy is removal of diseased fascia. Surgery is limited by prolonged recovery time, and many patients require multiple surgeries throughout their life as the disease progresses, with repeat surgeries increasing the risk of complications. Long recovery times and need for repeat surgeries has renewed interest in minimally invasive treatments for Dupuytren's disease. Percutaneous needle aponeurotomy (PNA) allows for rapid improvement in finger extension with minimal recovery time. The FDA approved collagenase clostridium histolyticum injection for Dupuytren's disease in 2010, which also allows for rapid increase in finger extension, also with minimal recovery time. Currently there is only one small study comparing PNA and collagenase injection (CI) that suggests similar outcomes in both treatments. Both treatments are minimally invasive, requiring minimal time off work and post-procedure pain. The main barrier to widespread adoption of CI is cost, particularly in patients with multiple areas of disease requiring treatment. The project proposed will compare these two methods for treating Dupuytren's disease. Approximately 334 participants will be recruited from patients referred for treatment to hand surgeons trained in CI and PNA at two Calgary, AB hospitals. Need for treatment will be determined in the usual fashion, and the option for entry into the study will be proposed to patients meeting inclusion/exclusion criteria. Participants will be randomized into either the PNA or CI treatment group. The surgeon will not be blinded to the procedure group; however, the therapist measuring outcomes will be, and the study participants will need to not divulge to the therapists which group they are in. Both procedures are performed under local freezing, and range from 5-20minutes. PNA involves the surgeon freezing the skin over the Dupuytren's cord, then using a small gauge needle inserted under the skin to cut the cord. This is repeated up the length of the cord to weaken it, allowing the surgeon to extend the finger and rupture the cord. CI involves the injection of collagenase (Xiaflex®), directly into the Dupuytren's cord. The patient then returns to see the surgeon within one week, has freezing placed in the hand, and the affected digit is extended to rupture the already weakened cord. The patient will be required to present to the hand therapist team for measurements of joint angles before and after the assigned treatment is performed. In order to measure treatment efficacy, study participants will be required to return for measurements of treated joints every 6 months. Lastly, participants will need to inform the performing surgeon or therapist, at follow-up visits of any complications they experience.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren Contracture, Dupuytren's Disease of Finger
Keywords
Collagenase injection, percutaneous needle aponeurotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Needle Aponeurotomy
Arm Type
Active Comparator
Arm Description
Percutaneous Needle Aponeurotomy (PNA) involves the surgeon anaesthetizing the skin over the Dupuytren's cord, then using a small gauge needle inserted percutaneously, cutting the cord with the sharp edge of the needle using a sweeping motion. This is repeated up the length of the cord to weaken it, allowing an extension force to be applied over the finger to rupture the cord.
Arm Title
Collagenase Injection
Arm Type
Active Comparator
Arm Description
Collagenase Injection (CI) involves the injection of collagenase clostridium histolyticum (0.58 mg), directly into the Dupuytren's cord. The patient then returns to see the surgeon within one week, has local anaesthetic is administered, and an extension force is applied to the affected digit to rupture the already weakened cord.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Needle Aponeurotomy
Other Intervention Name(s)
Percutaneous Needle Fasciotomy
Intervention Type
Drug
Intervention Name(s)
XIAFLEX
Other Intervention Name(s)
collagenase clostridium histolyticum
Primary Outcome Measure Information:
Title
Contracture Recurrence
Description
Recurrence defined by an increase in joint contracture of at least 30 degrees in presence of palpable cord, or the patient underwent repeat intervention to correct new/worsening contracture in the treated joint.
Time Frame
6 months - 5 years
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Survey
Time Frame
Intervention to 5 years post-intervention
Title
Complications
Description
Patient to Report
Time Frame
Intervention to 5 years post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients requiring treatment for functionally limiting Dupuytren's disease involving the MCP and PIP joints, defined as MCP joint contracture 20-100 degrees, PIP joint contracture 20-80 degrees and positive table top test. Patients must be over 18 years of age to enroll in the study. Exclusion Criteria: Patients who have had previous interventions of contracture presenting for treatment, in an effort to compare similar disease state and risk with each procedure. Disease involving DIP joint or thumb, as collagenase has not been approved for use in the thumb or DIP joints. Pregnant or nursing, although there is data indicating no detection of collagenase in patient serum following injection for Dupuytren's contractures, there is no data exploring the effects of collagenase on a fetus or infant. Anticoagulation therapy other than ASA (held 7 days prior to procedure), which is a recommendation by the manufacture of collagenase used in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Yeung, MD
Phone
403-800-9157
Email
Justin.Yeung2@albertahealthservices.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Hurdle, MD
Phone
4038161345
Email
vhurdle@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Yeung, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Yeung, MD
Phone
403-800-9157
Email
Justin.Yeung2@albertahealthservices.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21527148
Citation
Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011 May;36(5):936-42. doi: 10.1016/j.jhsa.2011.03.002.
Results Reference
background
Citation
Lermusiaux JL, Debeyre N. Le traitement médical de la maladie de Dupuytren. In: de Sèze S, Ryckewaert A, Kahn MF, Guérin CI. L'actualité rhumatologique 1979. Paris: Expansion Scientifique Française, 1980:338 -343.
Results Reference
background
PubMed Identifier
19726771
Citation
Hurst 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.
Results Reference
background
PubMed Identifier
21134613
Citation
Gilpin 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.
Results Reference
background
PubMed Identifier
24060510
Citation
Nydick JA, Olliff BW, Garcia MJ, Hess AV, Stone JD. A comparison of percutaneous needle fasciotomy and collagenase injection for dupuytren disease. J Hand Surg Am. 2013 Dec;38(12):2377-80. doi: 10.1016/j.jhsa.2013.08.096. Epub 2013 Sep 20.
Results Reference
background
PubMed Identifier
21981831
Citation
Chen NC, Shauver MJ, Chung KC. Cost-effectiveness of open partial fasciectomy, needle aponeurotomy, and collagenase injection for dupuytren contracture. J Hand Surg Am. 2011 Nov;36(11):1826-1834.e32. doi: 10.1016/j.jhsa.2011.08.004. Epub 2011 Oct 5.
Results Reference
background
PubMed Identifier
1769986
Citation
Smith AC. Diagnosis and indications for surgical treatment. Hand Clin. 1991 Nov;7(4):635-42; discussion 643.
Results Reference
background
PubMed Identifier
26096221
Citation
Peimer CA, Blazar P, Coleman S, Kaplan FT, Smith T, Lindau T. Dupuytren Contracture Recurrence Following Treatment With Collagenase Clostridium histolyticum (CORDLESS [Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study]): 5-Year Data. J Hand Surg Am. 2015 Aug;40(8):1597-605. doi: 10.1016/j.jhsa.2015.04.036. Epub 2015 Jun 18.
Results Reference
background
PubMed Identifier
16766101
Citation
van Rijssen AL, Werker PM. Percutaneous needle fasciotomy in dupuytren's disease. J Hand Surg Br. 2006 Oct;31(5):498-501. doi: 10.1016/j.jhsb.2006.03.174. Epub 2006 Jun 12.
Results Reference
background
PubMed Identifier
21705158
Citation
Zhang AY, Curtin CM, Hentz VR. Flexor tendon rupture after collagenase injection for Dupuytren contracture: case report. J Hand Surg Am. 2011 Aug;36(8):1323-5. doi: 10.1016/j.jhsa.2011.05.016. Epub 2011 Jun 25.
Results Reference
background
PubMed Identifier
21987045
Citation
van 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.
Results Reference
background

Learn more about this trial

Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease

We'll reach out to this number within 24 hrs