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

A Double-blinded Randomized Controlled Multicenter Trial Comparing Proximal ROw carpectOmy and Four-corner Fusion (PROOF) 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.

Study Overview

• Status: Recruiting
• Conditions: Wrist Osteoarthritis; Scapholunate Advanced Collapse
• Intervention / Treatment: Procedure: Proximal Row Carpectomy; Procedure: Four-corner fusion

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuli Aspinen, MD, PhD; Phone Number: +358406360546; Email: samuli.aspinen@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Töölö Hospital (Helsinki University Hospital)
    • Contact: Jorma Ryhänen, adj. prof; Email: jorma.ryhanen@hus.fi
  • Jyväskylä, Finland
    • Not yet recruiting
    • Central Hospital of Central Finland
    • Contact: Teemu Karjalainen, MD, PhD
  • Kotka, Finland
    • Not yet recruiting
    • Kymenlaakso Central Hospital
    • Contact: Kaj Zilliacus, MD
  • Tampere, Finland
    • Not yet recruiting
    • Tampere University Hospital
    • Contact: Veera Pikkarainen, MD
  • Turku, Finland
    • Not yet recruiting
    • Turku University Hospital
    • Contact: Hanna-Stiina Taskinen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proximal Row Carpectomy	Procedure: Proximal Row Carpectomy; Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
Active Comparator: Four-corner fusion	Procedure: Four-corner fusion; Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Rated Wrist Evaluation	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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick-Disabilities of the Arm, Shoulder and Hand	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)	12 months
Pain (Visual Analogue Scale)	The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain)	12 months
Global improvement	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	12 months
Grip strength	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	12 months
Wrist range of motion (ROM)	Wrist ROM is measured on both wrists with a handheld goniometer in degrees.	12 months
Complications	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.	12 months
Patient-rated Quality of Life (EQ-5D)		12 months
Cost-effectiveness	Quality-adjusted life years/months measured as a change in EQ-5D	12 months

Collaborators and Investigators

• Sponsor: Töölö Hospital
• Collaborators: Turku University Hospital; Tampere University Hospital; Jyväskylä Central Hospital; Kymenlaakso Central Hospital Kotka Finland

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2034

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Scapholunate Advanced Collapse; Wrist Osteoarthritis; Scaphoid Non-union Advanced Collapse; Wrist arthrodesis; Proximal Row Carpectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Shock
• Other Study ID Numbers: HUS/3487/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No