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NCT04260165: PROOF

Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist

Recruiting now NA Last updated 19 January 2021
What this trial tests

NA trial testing Proximal Row Carpectomy in Wrist Osteoarthritis in 84 participants. Currently enrolling.

Timeline
1 October 2020
Primary endpoint
31 December 2024
31 December 2034

Quick facts

Lead sponsorTöölö Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment84
Start date1 October 2020
Primary completion31 December 2024
Estimated completion31 December 2034
Sites5 locations across Finland

Drugs / interventions tested

Conditions studied

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):

  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 · · 2023 · PMID 37550711 · DOI 10.1186/s13063-023-07544-1
  2. 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:

Other trials of Proximal Row Carpectomy

Trials testing the same drug.

Other recruiting trials for Wrist Osteoarthritis

Currently open trials in the same condition.

Other Töölö Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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