Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370312
• Other study ID #: 2023-07921-01
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: April 2024
• Source: Region Skane
• Contact: Elisabeth Brogren, MD, PhD
• Phone: +46 40331723
• Email: elisabeth.brogren[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Osteoarthritis
• Osteoarthritis Thumb
• Osteoarthritis, Knee

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)