Menu
Recruiting NCT06370312

Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints

Observational Osteoarthritis Thumb Osteoarthritis, Knee Metabolic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trapeziectomy.
Who it may be relevant to
Registry conditions: Osteoarthritis Thumb, Osteoarthritis, Knee, Metabolic Disease. Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Serum cholesterol levels [Time frame: Serum cholesterol levels are drawn at baseline (i.e. the day of surgery)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 2 centers
  • Department of Hand Surgery, Skane University Hospital — Malmö
  • Aleris Specialistläkare Hyllie — Malmö

Identifiers

NCT: NCT06370312 · 2023-07921-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗