Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF

NCT ID: NCT02647619

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2022-04-30

Brief Summary

Aim:

Clinical RCT comparing functional results and recurrence rate following enzymatic treatment vs. needle aponeurotomy.

Materials and methods:

30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint. Patients with primary disease of the hand. Total of 80 patients needed to detect difference of 13.5°.

1) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks, 16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ, VAS pain and VAS patient satisfaction. Total passive extension contracture reduction, recurrence rate and registration of complications.

Detailed Description

Open surgery (fascieectomy) has traditionally been considered the gold standard of treatment for Dupytren´s disease (Dd) despite considerable risk of complications.

There is an increasing interest in Scandinavia in the treatment of Dd with Clostridium Histolyticum (Xiapex ®, Auxillium). However the enzyme is expensive and long-term effects are not well documented. More studies are needed to analyze both short and long term clinical outcome as well as cost-benefit analysis.

The treatment arm of Xiapex in this study follows the recommendation as by the producer.

The other treatment of Dd contracture in this study is needle fasiotomy/aponeurotomy. We use multiple perforation technigue with 26 G needle needle, with as little local anesthesia (xylocin w adrenaline) as needed during contionus extension of the finger untill successfully extended.

The two procedures leave little scar tissue lessening the challenges posed by the reoperations.

Recurrence rate of contracture following different treatments of Dupuytren's disease differs widely in the literature, and the rate is influenced by multiple factors.

Conditions

Dupuytren Contracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Needle aponeurotomy

percutaneous transection or pretendinous palmar dupytren cord

Group Type: ACTIVE_COMPARATOR

Needle aponeurotomy

Intervention Type: PROCEDURE

26 G needle multiple perforation tecqnique with local anesthetic

Xiapex

Injection of 0.58 mg collagenase into pretendinous palmar dupytren cord

Group Type: ACTIVE_COMPARATOR

Xiapex

Intervention Type: DRUG

Injection of collagenase of primary dupytren cord

Interventions

Xiapex

Injection of collagenase of primary dupytren cord

Intervention Type: DRUG

Needle aponeurotomy

26 G needle multiple perforation tecqnique with local anesthetic

Intervention Type: PROCEDURE

Other Intervention Names

Xiaflex; Percutaneous needle fasiotomy

Eligibility Criteria

Inclusion Criteria

• Primary Dd disease (no earlier treatment for this condition of the hand involved)
• Single digit involvement, one of the three ulnar digits
• Average norwegian language skills.
• MCPJ contracture of 30 degrees or more and less than 20 degree involvement of the adjacent PIPJ
• Minimum 18 y.o.

Exclusion Criteria

• Involvement of 2 fingers/joints
• Earlier treatment for Dd disease of the same hand, affection of addjecent PIPJ of 20 degrees or mor
• Pregnancy
• Ongoing treatment with platelet inhibitors
• Treatment with tetracycline 2 weeks prior to treatment date
• Poor norwegian language skills
• Participation in other studies 4 weeks prior or after treatment date
• "Need to treat" of both hands

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Ingi Thor Hauksson

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per-Henrik Randsborg, PhD

Role: STUDY_DIRECTOR

University Hospital, Akershus

Locations

Akershus University Hospital

Oslo, Akershus, Norway

Countries

Norway

Other Identifiers

2013-001221-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2639063

Identifier Type: -

Identifier Source: org_study_id