Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04260165

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

Led by Töölö Hospital · Updated on 2021-01-19

84

Participants Needed

5

Research Sites

743 weeks

Total Duration

On this page

Sponsors

T

Töölö Hospital

Lead Sponsor

T

Tampere University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with SLAC/SNAC II-III wrist osteoarthritis
  • Aged between 18 and 75 years
  • Wrist symptoms lasting more than 3 months
  • Physical status classified as American Society of Anaesthesiologists I or II
Not Eligible

You will not qualify if you...

  • Eligible for scapholunate reconstruction or scaphoid surgery
  • Presence of ulnocarpal or pancarpal arthritis
  • Lunate fossa or proximal lunate arthrosis
  • Younger than 18 or older than 75 years
  • Rheumatoid arthritis
  • Heavy smoking (more than 20 cigarettes per day)
  • Conditions or medications affecting bone healing, such as poorly controlled diabetes, malnutrition, or oral corticosteroid use
  • Alcohol or drug abuse
  • Neurological conditions affecting upper limb function

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Töölö Hospital (Helsinki University Hospital)

Helsinki, Finland

Actively Recruiting

2

Central Hospital of Central Finland

Jyväskylä, Finland

Not Yet Recruiting

3

Kymenlaakso Central Hospital

Kotka, Finland

Not Yet Recruiting

4

Tampere University Hospital

Tampere, Finland

Not Yet Recruiting

5

Turku University Hospital

Turku, Finland

Not Yet Recruiting

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Research Team

S

Samuli Aspinen, MD, PhD

CONTACT

J

Jorma Ryhänen, adj. prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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