Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370312
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-04-04
Brief Title:
Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None