Inflammatory Arthritis Clinical Trial
Official title:
Defining in Vivo Kinematics of Single Piece Silastic Joint Replacements in the Hand With Magnetic Resonance Imaging
NCT number | NCT05441462 |
Other study ID # | PIPJ |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 7, 2022 |
Est. completion date | January 13, 2023 |
Verified date | June 2023 |
Source | Wrightington, Wigan and Leigh NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To assess in vivo the kinematics of single piece silastic joint replacements in the hand with magnetic resonance imaging
Status | Completed |
Enrollment | 7 |
Est. completion date | January 13, 2023 |
Est. primary completion date | October 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Single piece silastic joint replacement with an adequate range of movement (ROM), i.e. an arc of movement of = 50 - Age over 18 - Able to give informed consent Exclusion Criteria: - Any contraindication to MRI scanning - Fractured implant - Fixed flexion deformity >30 degrees in the replaced joint - Total range of motion <50 degrees in the replaced joint - Awaiting further surgery - Abnormal joint instability - Previous surgery on the same digit (other than the joint replacement) - Replacement of the joint of the opposite hand |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust | Wigan |
Lead Sponsor | Collaborator |
---|---|
Wrightington, Wigan and Leigh NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Deformation Assesment - Assesment of deformation of single piece silastic joint replacements in vivo | Currently the only studies of single piece silastic joint replacement movements are in cadaveric models. These have shown there is a difference in the instantaneous centre of rotation between replacement and native joints. This has not been shown in vivo. As stated in the rational of the study the issue to address is the high failure rate of single piece silastic joint replacements in the hand. Key to this is understanding how they behave in vivo and how this differs from native joints. The primary objective is to show that in vivo displacement can be shown with MRI and is a reproducible method. Once the MRI scans have been obtained a computer generated 3D model of the scans will be made and measurements of deformation of the implant and its movements relative to the bony supporting structure will be made. | Six months | |
Secondary | To compare the movement of different implant designs and single replacements with native joints in combination with the assesment of acceptability and feasibility of MRI. | As this is an observational study there is no endpoint set other than the completed acquisition of the MRI sequences and the measurement of PROMS for each patient in the form of the patient rated wrist evaluation score and the quick disability of arm, shoulder and hand score. | Through study completion, an average of one year |
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