Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints

NCT ID: NCT06370312

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-04-30

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.

Conditions

Osteoarthritis Thumb; Osteoarthritis, Knee; Metabolic Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Trapeziectomy

Patients scheduled for trapeziectomy due to thumb basal joint osteoarthritis are invited to participate. Synovial fluid is aspirated before the joint is opened. Bone and cartilage are collected. Blood samples are obtained preop. Patients are measured with grip strength, pinch strength, range of thumb motion, body mass index, central obesity and blood pressure.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Brogren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of hand surgery, Region Skåne

Locations

Department of Hand Surgery, Skane University Hospital

Malmo, Skåne County, Sweden

Site Status: NOT_YET_RECRUITING

Aleris Specialistläkare Hyllie

Malmo, Skåne County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Elisabeth Brogren, MD, PhD

Role: CONTACT

elisabeth.brogren@med.lu.se

+46 40331723

My von Walter, MD

Role: CONTACT

Facility Contacts

Elisabeth Brogren, MD, PhD

Role: primary

elisabeth.brogren@med.lu.se

040-331723

My Winblad von Walter, MD

Role: primary

my@aleris.se

010-1690000

Anders Kjellin, MD

Role: backup

anders.kjellin@aleris.se

0431-371715

Other Identifiers

2023-07921-01

Identifier Type: -

Identifier Source: org_study_id