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Recruiting NCT04260165

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

No phase Interventional Wrist Osteoarthritis Scapholunate Advanced Collapse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Proximal Row Carpectomy, Four-corner fusion.
Who it may be relevant to
Registry conditions: Wrist Osteoarthritis, Scapholunate Advanced Collapse. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Proximal Row Carpectomy
    Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
  • Procedure Four-corner fusion
    Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate

Primary outcome measures

  • Patient-Rated Wrist Evaluation [Time frame: 12 months]
Secondary outcome measures (8)
  • Quick-Disabilities of the Arm, Shoulder and Hand [Time frame: 12 months]
  • Pain (Visual Analogue Scale) [Time frame: 12 months]
  • Global improvement [Time frame: 12 months]
  • Grip strength [Time frame: 12 months]
  • Wrist range of motion (ROM) [Time frame: 12 months]
  • Complications [Time frame: 12 months]
  • Patient-rated Quality of Life (EQ-5D) [Time frame: 12 months]
  • Cost-effectiveness [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Finland · 5 centers
  • Töölö Hospital (Helsinki University Hospital) — Helsinki
  • Central Hospital of Central Finland — Jyväskylä
  • Kymenlaakso Central Hospital — Kotka
  • Tampere University Hospital — Tampere
  • Turku University Hospital — Turku

Publications

  • Alanen M, Stjernberg-Salmela S, Waris E, Karjalainen T, Miettunen J, Ryhanen J, Aspinen S. Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial. Trials. 2023 Aug 7;24(1):499. doi: 10.1186/s13063-023-07544-1. PMID 37550711

Identifiers

NCT: NCT04260165 · HUS/3487/2019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗