Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints

NCT06370312 | Recruiting

• 1 other identifier: 2023-07921-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis Thumb; Osteoarthritis, Knee; Metabolic Disease

Outcome Measures

Primary Outcomes (1)

• Serum cholesterol levels

  Blood samples are drawn from the patients and analysed according to Swedish laboratory standards

  Serum cholesterol levels are drawn at baseline (i.e. the day of surgery)

Interventions

Trapeziectomy PROCEDURE

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.

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients fulfilling the eligibility criteria and are scheduled for surgery at any of two study centres; Department of hand surgery, Skane university hospital or Aleris Malmö Arena (private clinic), due to symptomatic thumb basal joint OA are invited to participate. Indications for surgery at these to clinics are; 1) persistent pain and pain at rest, 2) have tried conservative treatment with inadequate effect.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (2)

Department of Hand Surgery, Skane University Hospital

Malmo, Skåne County, 20502, Sweden

NOT YET RECRUITING

Aleris Specialistläkare Hyllie

Malmo, Skåne County, 21532, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Synovial fluid from thumb basal joint Bone and cartilage from thumb basal joint Blood samples

MeSH Terms

Conditions

Osteoarthritis, Knee; Metabolic Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Elisabeth Brogren, MD, PhD

  Department of hand surgery, Region Skåne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Brogren, MD, PhD

CONTACT

+46 40331723; elisabeth.brogren@med.lu.se

My von Walter, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 17, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)