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OpenTrials
Completed

NCT Number: NCT02647619

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Akershus University Hospital

Oslo, Akershus, 1478, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xiapex

Drug

Injection of collagenase of primary dupytren cord

Other names: Xiaflex

Needle aponeurotomy

Procedure

26 G needle multiple perforation tecqnique with local anesthetic

Other names: Percutaneous needle fasiotomy

Primary outcomes

  1. Reduction in Total Passive Extension Deficit

    Time frame: 5 years

Secondary outcomes

  1. Quick Dash (Disabilities of the shoulder and Hand)

    Time frame: 5 years

  2. EQ5D (Euroqol 5 Dimensions)

    Time frame: 5 years

  3. Brief MHQ (Michigan Hand Questionare)

    Time frame: 5 years

  4. URAM (Unité Rhumatologique des Affections de la Main)

    Time frame: 5 years

  5. Jamar grip strength

    Time frame: 1,4,26 weeks and one year.

  6. VAS (Visual analogue scale) pain

    Time frame: 1,4,26 weeks and one year

    0 is no pain, 10 maximum pain

  7. VAS (Visual analogue sale) satisfaction

    Time frame: 1,4,26 weeks. 1,2 and 5 years

    0 is not satisfied, 10 maximum satisfied

  8. Complications

    Time frame: 1,4,weeks One year

    AE,SAE,SUSAR

  9. Recurrence

    Time frame: 1,4,26 weeks. 1,2 and 5 years

    def. 30 degrees of treated MCP joint, or 20 or more degrees of adjecent PIPJ

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2016
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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