NCT03320291

Long-term Evaluation of Primary Trapeziectomy and Placement of a RegJoint Implant in the Treatment of Rhizarthrosis

Completed NA Last updated 17 April 2019

What this trial tests

NA trial testing Regjoint in Rhizarthrosis in 27 participants. Completed in 10 October 2018.

Timeline

1 November 2017

Primary endpoint
10 October 2018

10 October 2018

Quick facts

Lead sponsor	Brugmann University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 November 2017
Primary completion	10 October 2018
Estimated completion	10 October 2018
Sites	2 locations across Belgium

Drugs / interventions tested

• Regjoint

Conditions studied

• Rhizarthrosis — all drugs for Rhizarthrosis →

Sponsor

Brugmann University Hospital

Who can join

18 and older, any sex, with Rhizarthrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In a society based on the use of everyday tools and objects, the loss of function of one or both thumbs due to Rhizarthrosis can drastically reduce the quality of life. Many patients are refractory to preservative treatments.Therefore, multiple arthroplasty techniques were developed.

Trapeziectomy, with or without tendon interposition, gives very good results in terms of pain, function or force. However, it can result in a reduction of the size of the column of the thumb, therefore leading to a loss of force.

Replacement of the trapezo-metacarpal joint with prosthetic material is also proposed and has the advantage to avoid the reduction of the thumb column. Several models are available, mono or bipolar, with a conical or hemispherical cup. Another option is the placement of implants. They were first used when a partial trapeziectomy was possible to counter the collapse of the column and are made of different materials such as metal, silicone, ceramic, pyrocarbon , and gelfoam.

The bioabsorbable poly-LD-lactide implant (PLDLA) is a relatively new possibility for the reconstruction of small joints. Studies have previously revealed that the PLDLA implant is biocompatible and represents a good alternative to arthroplasty by tendon interposition in the reconstruction of the trapezo-metacarpal articulation with osteoarthritis.

In this study, the investigators will investigate the long term effects (1 year after placement) of the Regjoint, a poly-LD-lactide implant (PLDLA).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.