A Double-blinded Randomized Controlled Multicenter Trial Comparing Proximal ROw carpectOmy and Four-corner Fusion (PROOF) for Osteoarthritis of the Wrist

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting. Patients with radiologically and clinically confirmed OA are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either PRC or FCA. The study will be patient and assessor blinded. Baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. Unveiling of the allocation is at 12 months post-intervention.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• SLAC/SNAC II-III

• Age 18 - 75

• Symptom duration \> 3 months

• American Society of Anaesthesiologists physical status (ASA) I-II

Locations
Other Locations
Finland
Töölö Hospital (Helsinki University Hospital)
RECRUITING
Helsinki
Central Hospital of Central Finland
NOT_YET_RECRUITING
Jyväskylä
Kymenlaakso Central Hospital
NOT_YET_RECRUITING
Kotka
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Turku University Hospital
NOT_YET_RECRUITING
Turku
Contact Information
Primary
Samuli Aspinen, MD, PhD
samuli.aspinen@hus.fi
+358406360546
Backup
Jorma Ryhänen, adj. prof.
jorma.ryhanen@hus.fi
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 84
Treatments
Experimental: Proximal Row Carpectomy
Active_comparator: Four-corner fusion
Authors
Susanna Stjernberg-Salmela, Eero Waris
Related Therapeutic Areas
Sponsors
Collaborators: Kymenlaakso Central Hospital Kotka Finland, Tampere University Hospital, Jyväskylä Central Hospital, Turku University Hospital
Leads: Töölö Hospital

This content was sourced from clinicaltrials.gov

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