Skip to main content
Clinical Trials/NCT06370312
NCT06370312
Recruiting
Not Applicable

Analysis of Synovial Fluid, Bone and Articular Cartilage From Osteoarthritic First Carpometacarpal Joints in Relationship to Metabolic Risk Factors and Patient-reported Hand Function

Region Skane2 sites in 1 country120 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis Thumb
Sponsor
Region Skane
Enrollment
120
Locations
2
Primary Endpoint
Serum cholesterol levels
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
April 30, 2027
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Serum cholesterol levels

Time Frame: 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

Study Sites (2)

Loading locations...

Similar Trials