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

NCT04260165 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-01-19

No results posted yet for this study

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.

Conditions

  • Wrist Osteoarthritis
  • Scapholunate Advanced Collapse

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

Sponsors & Collaborators

  • Tampere University Hospital

    collaborator OTHER

  • Turku University Hospital

    collaborator OTHER_GOV

  • Jyväskylä Central Hospital

    collaborator OTHER

  • Kymenlaakso Central Hospital Kotka Finland

    collaborator OTHER

  • Töölö Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2024-12-31
Completion
2034-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04260165 on ClinicalTrials.gov