Actively Recruiting
Led by Töölö Hospital · Updated on 2021-01-19
84
Participants Needed
5
Research Sites
521 weeks
Total Duration
T
Töölö Hospital
Lead Sponsor
T
Tampere University Hospital
Collaborating Sponsor
Researchers are comparing two surgical treatments for wrist osteoarthritis called proximal row carpectomy (PRC) and four-corner fusion (FCA) in patients with SLAC or SNAC type II-III osteoarthritis. This double-blinded randomized controlled study aims to evaluate which procedure leads to better wrist function and patient outcomes. Patients with confirmed wrist osteoarthritis will be randomly assigned to one of these two treatments and neither the patients nor assessors will know the treatment allocation until 12 months after surgery. Participants will undergo either PRC, which involves removing the proximal carpal row including the scaphoid, lunate, and triquetrum bones, or FCA, which includes scaphoid excision and fusion of the four remaining wrist bones using screws or plates. The study includes baseline assessments before surgery and follow-up visits at 2 and 6 weeks, then at 3, 6, 12 months, and long-term follow-ups at 5 and 10 years post-intervention. The treatment assignment will be revealed after the 12-month visit. Throughout the study, participants will be evaluated on wrist function using the Patient-Rated Wrist Evaluation at 12 months, along with other measures such as pain levels, grip strength, wrist range of motion, complications, quality of life, and cost-effectiveness. Follow-up visits include clinical assessments and questionnaires to monitor progress and safety. The total participation duration can extend up to 10 years with regular check-ins to assess long-term outcomes.
CONDITIONS
Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo either Proximal Row Carpectomy or Four-corner Fusion surgery to treat wrist osteoarthritis, followed by immediate post-operative care.
1 surgery visit and approximately 2 post-operative visits
Duration - Up to 12 months
Participants are monitored and assessed for recovery, wrist function, pain, and quality of life after surgery.
Regular follow-up visits over 12 months
Total: 5 locations
1
Töölö Hospital (Helsinki University Hospital)
Helsinki, Finland
Actively Recruiting
2
Central Hospital of Central Finland
Jyväskylä, Finland
Not Yet Recruiting
3
Kymenlaakso Central Hospital
Kotka, Finland
Not Yet Recruiting
4
Tampere University Hospital
Tampere, Finland
Not Yet Recruiting
5
Turku University Hospital
Turku, Finland
Not Yet Recruiting
S
Samuli Aspinen, MD, PhD
J
Jorma Ryhänen, adj. prof.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Mikko Alanen, Susanna Stjernberg-Salmela, Eero Waris...
https://pubmed.ncbi.nlm.nih.gov/37550711