Kinematics of Silastic Joint Replacements in the Hand

NCT05441462 | Completed

• 1 other identifier: PIPJ
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To assess in vivo the kinematics of single piece silastic joint replacements in the hand with magnetic resonance imaging

Conditions

Degenerative Arthritis; Inflammatory Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  Through study completion, an average of one year

Interventions

Silastic Joint Replacement PROCEDURE

Participants who have had silastic joint replacement surgery for degenerative or inflammatory arthritis within the last three years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are over the age of 18, able to give informed consent and have had a sialastic joint replacement and a native joint on the contralateral hand will be eligible for the study.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wrightington, Wigan and Leigh NHS Foundation Trust: lead

Study Sites (1)

Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Wigan, WN6 9EP, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: July 1, 2022
• Study Start: April 7, 2022
• Primary Completion: October 5, 2022
• Study Completion: January 13, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)