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

Not Applicable

Not yet recruiting

• Conditions: Wrist Arthritis; Fusion; Joint
• Interventions: Procedure: PRC; Procedure: TWA

• Registration Number: NCT04403958
• Lead Sponsor: Töölö Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30
• Study Start: 2021-09-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRC	PRC	Total wrist arthrodesis with PRC and dorsal plate
TWA	TWA	Total wrist arthrodesis with dorsal plate

Primary Outcome Measures

Name	Time	Method
Fusion rate (percent)	6 months

Secondary Outcome Measures

Name	Time	Method
Global improvement	6 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
Patient-Rated Wrist Evaluation (PRWE)	6 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)
Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)	6 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)
Operative time	Perioperative	Operative time is measured in minutes for time in the operation theatre and time used for surgery
Pain (Visual Analogue Scale)	6 months	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)
Complications	12 months	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.
Grip strength	6 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