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NCT Number: NCT06370312

Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints

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.

Recruiting

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aleris Specialistläkare Hyllie, Malmö, Skåne County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Brogren, MD, PhD

CONTACT

[email protected]

+46 40331723

My von Walter, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2024
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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