RecruitingNot ApplicableNCT04260165

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

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


Sponsor

Töölö Hospital

Enrollment

84 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • SLAC/SNAC II-III
  • Age 18 - 75
  • Symptom duration > 3 months
  • American Society of Anaesthesiologists physical status (ASA) I-II

Exclusion Criteria9

  • 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

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Interventions

PROCEDUREProximal Row Carpectomy

Excision of the proximal carpal row - the scaphoid, lunate and triquetrum

PROCEDUREFour-corner fusion

Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate


Locations(5)

Töölö Hospital (Helsinki University Hospital)

Helsinki, Finland

Central Hospital of Central Finland

Jyväskylä, Finland

Kymenlaakso Central Hospital

Kotka, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

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NCT04260165