Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints

Recruiting

• Conditions: Osteoarthritis Thumb; Osteoarthritis, Knee; Metabolic Disease

• Registration Number: NCT06370312
• Lead Sponsor: Region Skane

Brief Summary

The study project aims at examining molecular markers in synovial fluid, bone and articular cartilage from osteoarthritic thumb basal joints. The degradation of extracellular matrix (ECM) proteins in thumb basal joints will be evaluated in association to the metabolic profile of the patient, but we also aim to compare the ECM degradation and inflammatory profiles with articular cartilage degradation ECM profile from knee joints with osteoarthritis. A third aim is to evaluate associations between patient-reported hand function, pain, strength and range of thumb motion to analyses of synovial fluid.

Detailed Description

Patients scheduled for trapeziectomy on the basis of thumb basal joint osteoarthritis will be asked to participate. Synovial fluid from the thumb basal joint is aspirated before the joint is opened. The trapezium bone and cartilage is harvested. Blood samples to evaluated lipid profile and glucose intolerance is drawn. Blood pressure and measurements of obesity is taken. Patients are also examined at baseline and 1 year postop with grip strength, pinch strength, range of thumb motion and asked to fill in patient-rated outcome measures; QuickDASH and NRS pain.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Study Start: 2024-05-01
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2026-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Men and women age ≥ 25 years
• Radiologically confirmed and symptomatic thumb basal joint osteoarthritis (OA) planned for trapeziectomy

Exclusion Criteria

• Previous surgery to the affected thumb basal joint
• Post-traumatic thumb basal joint OA
• Rheumatoid arthritis or other chronic inflammatory arthritis, history of psoriasis affecting joints, gout or pseudogout
• Ongoing infection in the hand or wrist
• Inability to co-operate with the follow-up protocol or to assimilate information about the study protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction)
• Systemic or intra-articular glucocorticoids or intraarticular platelet-rich plasma or hyaluronic acid injections in the affected joint within 3 months prior to enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum cholesterol levels	Serum cholesterol levels are drawn at baseline (i.e. the day of surgery)	Blood samples are drawn from the patients and analysed according to Swedish laboratory standards

Trial Locations

Locations (2)

Department of Hand Surgery, Skane University Hospital; 🇸🇪 Malmö, Skåne, Sweden

Aleris Specialistläkare Hyllie; 🇸🇪 Malmö, Skåne, Sweden