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

Töölö Hospital

Status: Not yet enrolling

Conditions: Wrist Arthritis; Fusion; Joint

Treatments: Procedure: TWA; Procedure: PRC

Study type: Interventional

Funder types: Other

Identifiers

NCT04403958

1467/2020

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

PRC

Experimental group

Description:

Total wrist arthrodesis with PRC and dorsal plate

Treatment:

Procedure: PRC

TWA

Active Comparator group

Description:

Total wrist arthrodesis with dorsal plate

Treatment:

Procedure: TWA