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

Wrist Osteoarthritis Clinical Trial

— PROOF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04260165
• Other study ID #: HUS/3487/2019
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2034

Study information

• Verified date: January 2021
• Source: Töölö Hospital
• Contact: Samuli Aspinen, MD, PhD
• Phone: +358406360546
• Email: samuli.aspinen[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2034
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Scapholunate Advanced Collapse
• Shock
• Wrist Osteoarthritis

Intervention

Procedure:
• Proximal Row Carpectomy
Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
• Four-corner fusion
Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate

Locations

Country	Name	City	State
Finland	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

Sponsors (5)

Lead Sponsor	Collaborator
Töölö Hospital	Jyväskylä Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Tampere University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Wrist range of motion (ROM)	Wrist ROM is measured on both wrists with a handheld goniometer in degrees.	12 months
Secondary	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
Secondary	Patient-rated Quality of Life (EQ-5D)		12 months
Secondary	Cost-effectiveness	Quality-adjusted life years/months measured as a change in EQ-5D	12 months