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

Wrist Arthritis Clinical Trial

— PROOF II  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04403958
• Other study ID #: 1467/2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2021
• Source: Töölö Hospital
• Contact: Samuli Aspinen, M.D., Ph.D.
• 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosis
• Arthritis
• Fusion; Joint
• Wrist Arthritis

Intervention

Procedure:
• PRC
Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
• TWA
Total wrist arthrodesis with dorsal plate using iliac crest as bone graft

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion rate (percent)		6 months
Secondary	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
Secondary	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
Secondary	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
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	6 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	6 months
Secondary	Operative time	Operative time is measured in minutes for time in the operation theatre and time used for surgery	Perioperative
Secondary	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