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NCT Number: NCT04260165

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

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.

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Key information

Conditions

Wrist Osteoarthritis Scapholunate Advanced Collapse

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Töölö Hospital (Helsinki University Hospital), Helsinki, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proximal Row Carpectomy

Procedure

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

Four-corner fusion

Procedure

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

Primary outcomes

  1. Patient-Rated Wrist Evaluation

    Time frame: 12 months

    The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)

Secondary outcomes

  1. Quick-Disabilities of the Arm, Shoulder and Hand

    Time frame: 12 months

    The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)

  2. Pain (Visual Analogue Scale)

    Time frame: 12 months

    The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain)

  3. Global improvement

    Time frame: 12 months

    Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better

  4. Grip strength

    Time frame: 12 months

    Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side

  5. Wrist range of motion (ROM)

    Time frame: 12 months

    Wrist ROM is measured on both wrists with a handheld goniometer in degrees.

  6. Complications

    Time frame: 12 months

    Incidence of complications (i.e. non-union, fracture, reoperation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.

  7. Patient-rated Quality of Life (EQ-5D)

    Time frame: 12 months

  8. Cost-effectiveness

    Time frame: 12 months

    Quality-adjusted life years/months measured as a change in EQ-5D

Study contacts

Contact information is provided by the study sponsor or research team.

Jorma Ryhänen, adj. prof.

CONTACT

[email protected]

Samuli Aspinen, MD, PhD

CONTACT

[email protected]

+358406360546

Sponsors and collaborators

Lead sponsor

Töölö Hospital

Other

Collaborators

  • Jyväskylä Central Hospital
  • Kymenlaakso Central Hospital Kotka Finland
  • Tampere University Hospital
  • Turku University Hospital

Registry information

Official study title

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

Acronym: PROOF

Important dates

Study start
2020
Primary completion
2024
Study completion
2034
First posted
Feb 7, 2020
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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