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Poly-L/D-lactide Implant (RegJoint) Versus Tendon Interposition for Trapeziometacarpal Inflammatory Arthritis: a 15-year Follow-up

NCT06804356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-02-03

No results posted yet for this study

Summary

This is a late (about 15 years) follow-up study of a randomized prospective clinical study originally conducted as a collaboration of the Rheumatism Foundation Hospital, Heinola, Finland and Päijät-Häme Central Hospital, Lahti Finland.

For the original study thirty-five patients with symptomatic end-stage inflammatory arthritis of the trapeziometacarpal joint were recruited. All patients signed written informed consent and were randomised to undergo surgery using either tendon interposition or poly-L-D-lactic acid implant interposition arthroplasty of said joint. The study was approved by the Päijät-Häme hospital district ethics committee.

Results of up to two years of follow-up have been published previously (DOI: 10.3109/2000656X.2012.669202).

For the current study all patients included in the final data analysis of the original study are to be contacted for a late follow-up using the same metrics used in the original study (hand pain and hand function rated on a visual analogue scale, hand strenght measurements, hand range of motion measurements, hand dexterity tests and tests simulating hand function in activities of daily living). Additionally outcomes will be assessed using the Patient Rated Wrist/Hand Evaluation and QuickDASH clinical outcome measurement scores.

Collected follow-up data will be statistically analyzed and a summary will be published in a peer-reviewed scientific journal.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

PROCEDURE

Tendon interposition arthroplasty

Trapeziometacarpal arthroplasty using autologous tendon interposition to fill the space left by resecting affected joint surfaces.

PROCEDURE

Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty

Trapeziometacarpal arthroplasty using poly-L-D-lactic acid implant (RegJoint) interposition to fill the space left by resecting affected joint surfaces.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2020-04-02
Completion
2020-04-02

Countries

  • Finland

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 NCT06804356 on ClinicalTrials.gov