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

University Hospital, Akershus

Status and phase

Completed

Phase 4

Conditions

Dupuytren Contracture

Treatments

Procedure: Needle aponeurotomy

Drug: Xiapex

Study type

Interventional

Funder types

Other

Identifiers

NCT02647619

2639063

2013-001221-13 (EudraCT Number)

Details and patient eligibility

About

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°.

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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