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

NCT04403958 | Unknown

• 1 other identifier: 1467/2020
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wrist Arthritis; Fusion; Joint

Outcome Measures

Primary Outcomes (1)

• Fusion rate (percent)

  6 months

Secondary Outcomes (7)

• Pain (Visual Analogue Scale)

  6 months

• Patient-Rated Wrist Evaluation (PRWE)

  6 months

• Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)

  6 months

• Global improvement

  6 months

• Grip strength

  6 months

Study Arms (2)

PRC

EXPERIMENTAL

Total wrist arthrodesis with PRC and dorsal plate

Procedure: PRC

TWA

ACTIVE COMPARATOR

Total wrist arthrodesis with dorsal plate

Procedure: TWA

Interventions

PRC PROCEDURE

Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft

PRC

TWA PROCEDURE

Total wrist arthrodesis with dorsal plate using iliac crest as bone graft

TWA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Töölö Hospital: lead
• Turku University Hospital: collaborator
• Kymenlaakso Central Hospital Kotka Finland: collaborator

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Samuli Aspinen, M.D., Ph.D.

  HUS Töölö Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuli Aspinen, M.D., Ph.D.

CONTACT

+358406360546; samuli.aspinen@hus.fi

Jorma Ryhänen, adj. prof.

CONTACT

jorma.ryhanen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: September 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share