Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis, Knee; Osteoarthritis Thumb; Metabolic Disease
• Intervention / Treatment: Procedure: Trapeziectomy

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Elisabeth Brogren, MD, PhD; Phone Number: +46 40331723; Email: elisabeth.brogren@med.lu.se
• Study Contact Backup: Name: My von Walter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Elisabeth Brogren, MD, PhD, Department of hand surgery, Region Skåne

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Metabolic Diseases
• Other Study ID Numbers: 2023-07921-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No