Comparing two surgical options for wrist osteoarthritis
A Double-blinded Randomized Controlled Multicenter Trial Comparing Proximal ROw carpectOmy and Four-corner Fusion (PROOF) for Osteoarthritis of the Wrist
NA · Töölö Hospital · NCT04260165
This study is testing which surgery, either proximal row carpectomy or four-corner fusion, works better for people with certain types of wrist osteoarthritis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Töölö Hospital (other) |
| Locations | 5 sites (Helsinki and 4 other locations) |
| Trial ID | NCT04260165 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of proximal row carpectomy (PRC) versus four-corner fusion (FCA) in patients with SLAC/SNAC II-III type osteoarthritis of the wrist. Patients with confirmed osteoarthritis will be randomly assigned to one of the two surgical procedures in a double-blinded manner. Data will be collected preoperatively and during follow-up visits at various intervals up to 10 years post-surgery to assess the effectiveness of each intervention. The allocation of treatment will remain concealed until the 12-month follow-up.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with SLAC/SNAC II-III osteoarthritis and a symptom duration of more than three months.
Not a fit: Patients with conditions such as rheumatoid arthritis, significant smoking habits, or those with other factors affecting bone healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective surgical treatment for wrist osteoarthritis, potentially improving patient outcomes.
How similar studies have performed: Previous studies have explored similar surgical interventions for wrist osteoarthritis, but this specific comparison of PRC and FCA is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * SLAC/SNAC II-III * Age 18 - 75 * Symptom duration \> 3 months * American Society of Anaesthesiologists physical status (ASA) I-II Exclusion Criteria: * Patient eligible for SL reconstruction or scaphoid * Ulnocarpal/pancarpal arthritis * Lunate fossa, proximal lunate arthrosis or both * Age \<18 or \>75 years * Rheumatoid arthritis * Heavy smoking (\> 20 cigarettes per day) * Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids) * Alcohol or drug abuse * Neurological condition affecting upper limb function
Where this trial is running
Helsinki and 4 other locations
- Töölö Hospital (Helsinki University Hospital) — Helsinki, Finland (RECRUITING)
- Central Hospital of Central Finland — Jyväskylä, Finland (NOT_YET_RECRUITING)
- Kymenlaakso Central Hospital — Kotka, Finland (NOT_YET_RECRUITING)
- Tampere University Hospital — Tampere, Finland (NOT_YET_RECRUITING)
- Turku University Hospital — Turku, Finland (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Samuli Aspinen, MD, PhD
- Email: samuli.aspinen@hus.fi
- Phone: +358406360546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Wrist Osteoarthritis, Scapholunate Advanced Collapse, Scaphoid Non-union Advanced Collapse, Wrist arthrodesis, Proximal Row Carpectomy