A prospective randomised pilot study comparing patient outcomes and cost-effectiveness of injectable collagenase fasciotomy with percutaneous needle fasciotomy for the treatment of Dupuytren’s disease of the hand

For people with Dupuytren's disease of the hand, is treatment with percutaneous fasciotomy as effective as injectable collagenase in improving functionality and fixed flexure angles.

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001240235

Acronym

Nil

Enrollment

100

Registered

2018-07-23

Start date

2019-10-01

Completion date

2020-10-01

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to compare two treatments for the management of Dupuytren's disease of the hand. The two treatments can both be performed in the surgeons rooms without requiring a major surgical procedure. The two treatments are 1) the use of a needle to divide the tissue causing the contracture, and 2) the use of a chemical substance to break down the tissue causing the contracture. The hypothesis of this study is that the use of needle is as effective as the use of a chemical substance, and less expensive.

Interventions

Percutaneous Needle Fasciotomy is a minimally invasive procedure and involves the division and release of the flexion contracture using a needle. Local anesthetic is injected into palm of hand at the site of the Dupuytren bands. This serves two purposes, to numb the hand and to separate the band from surrounding tissue. A fine needle is then used to repeatedly puncture the band so it weakens and breaks. Each Dupuytren effected band is broken in 2 places. It is done as a single procedure, and multiple bands can be treated at the same time. The length of the procedure depends on the number of bands that are treated, approximately 5 minutes per band, after allowing 5-10 minutes for the anaesthetic to take effect. The intervention will be adminsitered by one of two Plastic Surgeons who are part of the research team.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Dupuytren’s disease with contracture (20-100 degrees Metacarpo-phalyngeal (MCP) joint or 20-80 at the proximal interphalyngeal (PIP) joint.) Consulting clinician deems it appropriate management for the patient to have one or other of the fasciotomy procedures No previous treatment within 90 days Able to provide informed consent; age 18 years and older

Exclusion criteria

Bleeding disorder, blood thinning treatment (except aspirin 150mg/day) Allergy to collagenase ; pregnancy, breast feeding; neuromuscular disorders Administration of tetracyclines, antracyclines or anthraquinones in the past 14 days (these meds inhibit matrix metalloproteinase-mediate collagen degradation at suprapharmacological concentrations in vitro).

Outcome results