The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion (PROOF II)

The Use of Proximal Carpal Row Versus Iliac Crest Bone Graft in Total Wrist Fusion - a Randomized Controlled Multicenter Trial Comparing Two Operative Techniques (PROOF II - Trial)

Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone graft.

Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting.

Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the primary outcome is fusion rate.

Study Overview

• Status: Not yet recruiting
• Conditions: Wrist Arthritis; Fusion; Joint
• Intervention / Treatment: Procedure: PRC; Procedure: TWA

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 - 75
• Symptom duration > 3 months
• American Society of Anaesthesiologists physical status (ASA) I-III
• Fluent in written and spoken Finnish

Exclusion Criteria:

• 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)
• Ulnar variance > 1 mm
• Wrist pain treatable with partial wrist fusion
• Previous partial wrist fusion
• Alcohol or drug abuse
• Neurological condition affecting upper limb function
• Less than 6 months after another operation of the same upper limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PRC; Total wrist arthrodesis with PRC and dorsal plate	Procedure: PRC; Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
ACTIVE_COMPARATOR: TWA; Total wrist arthrodesis with dorsal plate	Procedure: TWA; Total wrist arthrodesis with dorsal plate using iliac crest as bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fusion rate (percent)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (Visual Analogue Scale)	The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)	6 months
Patient-Rated Wrist Evaluation (PRWE)	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)	6 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	6 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	6 months
Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)	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)	6 months
Operative time	Operative time is measured in minutes for time in the operation theatre and time used for surgery	Perioperative
Complications	Incidence of complications (i.e. non-union, fracture, re-operation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Ankylosis
• Other Study ID Numbers: 1467/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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