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

NCT03320291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-04-17

No results posted yet for this study

Summary

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).

Conditions

  • Rhizarthrosis

Interventions

DEVICE

Regjoint

Implant of poly-L / D-lactide (Regjoints®) in the treatment of trapezo-metacarpal osteoarthritis

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Principal Investigators

  • Morgan Gason, MD · CHU Brugmann

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-10-10
Completion
2018-10-10

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03320291 on ClinicalTrials.gov