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NCT04260165: PROOF
Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist
NA trial testing Proximal Row Carpectomy in Wrist Osteoarthritis in 84 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Töölö Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 1 October 2020 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2034 |
| Sites | 5 locations across Finland |
Drugs / interventions tested
- Proximal Row Carpectomy
- Four-corner fusion
Conditions studied
- Wrist Osteoarthritis — all drugs for Wrist Osteoarthritis →
- Scapholunate Advanced Collapse — all drugs for Scapholunate Advanced Collapse →
Sponsor
Töölö Hospital
Who can join
Adults 18 to 75, any sex, with Wrist Osteoarthritis or Scapholunate Advanced Collapse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial.
Alanen M, Stjernberg-Salmela S, Waris E, Karjalainen T, et al · · 2023 · PMID 37550711 · DOI 10.1186/s13063-023-07544-1 -
Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: Study protocol for multi-institutional double-blinded randomized controlled trial
Alanen M, Stjernberg-Salmela S, Waris E, Karjalainen T, et al · · 2022 · DOI 10.21203/rs.3.rs-2230205/v1
Verify or expand the search:
- PubMed search for NCT04260165
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Proximal Row Carpectomy
Trials testing the same drug.
- NCT05412615 — PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis · NA · recruiting
Other recruiting trials for Wrist Osteoarthritis
Currently open trials in the same condition.
- NCT06917235 — Wrist and Carpal Arthrodeses. A 1-year Follow-up Study. · recruiting
- NCT05412615 — PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis · NA · recruiting
Other Töölö Hospital trials
Trials by the same sponsor.
- NCT06365710 — Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture · NA · recruiting
- NCT04403958 — The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion · NA · unknown
- NCT04826380 — Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-u · NA · unknown
- NCT04323410 — Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures · NA · recruiting
- NCT04167098 — Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04260165 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Töölö Hospital
- Last refreshed: 19 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04260165.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing