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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Rheumatoid Arthritis (RA)

Treatments: Procedure: Poly-L-D-lactic acid implant (RegJoint) interposition arthroplasty; Procedure: Tendon interposition arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06804356

HUS/575/2019

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteriria:

Patients of the study the results of which are reported in the following article: DOI: 10.3109/2000656X.2012.669202

Inclusion criteria for the original study:

• Symptomatic end- stage inflammatory arthritis of the trapeziometacarpal joint
• Trapeziometacarpal arthroplasty at Rheumatism Foundation Hospital, Heinola between january 2004 and december 2005
• Signed written informed consent

Exclusion criteria for the original study:

-age less than 18 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Tendon interposition arthroplasty

Active Comparator group

Description:

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

Treatment:

Procedure: Tendon interposition arthroplasty

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

Active Comparator group

Description:

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

Treatment:

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