NCT06804356

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

Long-term Outcome of Partial Trapeziectomy With Interposition of Poly-L/D-lactide Scaffold (RegJoint) vs. Autologous Tendon for Inflammatory Trapeziometacarpal Joint Arthritis.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-10-09
• Primary completion: 2020-04-02
• Completion: 2020-04-02
• First posted: 2025-02-03
• Last updated: 2025-02-03

Locations

1 site across 1 country: Finland