Clinical trial NCT06804356: Poly-L/D-lactide Implant (RegJoint) Versus Tendon Interposition for Trapeziometacarpal Inflammatory Arthritis: a 15-year Follow-up
Official title: Long-term Outcome of Partial Trapeziectomy With Interposition of Poly-L/D-lactide Scaffold (RegJoint) vs. Autologous Tendon for Inflammatory Trapeziometacarpal Joint Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Hand pain
timeFrame: Approximately 15 years from enrollment
measure: Hand function
timeFrame: Approximately 15 years from enrollment
measure: Hand grip strength
timeFrame: Approximately 15 years from enrollment
measure: QuickDASH score
timeFrame: The previous week before approximately 15 years from enrollment
measure: Hand range of motion
timeFrame: Approximately 15 years from enrollment
measure: Box and block dexterity test
timeFrame: Approximately 15 years from enrollment
measure: Simulated activities of daily living tests
timeFrame: Approximately 15 years from enrollment
measure: Radiological results
timeFrame: Approximately 15 years from enrollment
measure: Patient Rated Wrist/Hand Evaluation clinical outcome measure
timeFrame: The previous week before approximately 15 years from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
References:
citation: Tiihonen RP, Skytta ET, Kaarela K, Ikavalko M, Belt EA. Reconstruction of the trapeziometacarpal joint in inflammatory joint disease using interposition of autologous tendon or poly-L-D-lactic acid implants: a prospective clinical trial. J Plast Surg Hand Surg. 2012 Apr;46(2):113-9. doi: 10.3109/2000656X.2012.669202.