Degenerative ArthritisNCT05441462
Kinematics of Silastic Joint Replacements in the Hand
An observational study of Degenerative Arthritis and Inflammatory Arthritis, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To assess in vivo the kinematics of single piece silastic joint replacements in the hand with magnetic resonance imaging Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Arthritis, Inflammatory Arthritis
- What is being tested?
- Silastic Joint Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Apr 2022to 13 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, WN6 9EP
About this study
Official title: Defining in Vivo Kinematics of Single Piece Silastic Joint Replacements in the Hand With Magnetic Resonance Imaging
To assess in vivo the kinematics of single piece silastic joint replacements in the hand with magnetic resonance imaging
Read the detailed description
Proximal inter phalangeal joint (PIPJ) replacement is performed for pain relief in the end stage of arthritis. Rheumatoid arthritis is the commonest indication in the metacarpophalangeal joint (MCPJ). In the PIPJ there is a more even spilt between degenerative and rheumatoid arthritis.
There are several options for PIPJ replacement currently licensed for use in the United Kingdom although data is not entered in to the National Joint Registry so the exact numbers and failure rates are unknown. Data from the Norwegian joint registry indicates that 99% of implanted MCPJ and PIPJ replacements are single piece silastic implants.
Three main prostheses represent the majority of implants used in the United Kingdom, Swanson, Sutter and Neuflex. All these implants have been shown in the literature to fracture either at the hinge or the distal stem - hinge interface. This is true of explants and in vitro simulator testing.
Long term survivorship in MCPJ and PIPJ replacement is below that of hip and knee replacement. One of the largest single series shows 63% survivorship at 17 year follow up but with radiological evidence of failure in at least two thirds. This compares poorly to the 82.9% survivorship for Exeter cemented hip replacements at 22 years. The long term aim of this project is to understand how the implants move. This will help explain failure in particular the newly observe hinge failure in Neuflex implants and provide ideas to improve these implants. Any modifications can be tested on the in vitro finger joint testing rig The method of MRI acquisition will be similar to that described in. This will require optimising. In order to limit movement to a sagittal displacement, a thermoplastic splint will support the wrist and hand up to the level of the proximal palmer crease. A rig will also be made to hold the MCP / PIP joints in extension and positions of flexion increasing by 200 to maximum flexion. These will depend upon the patient's range of motion. The Investigators will define the centre of rotation of the hinge then points on the shoulder and stem of the implant from which to measure displacement. Points on the metacarpal and proximal phalanx will also be defined to allow measurement of the displacement of the implant relative to the bone during the range of movement.
- Conditions
- Degenerative Arthritis, Inflammatory Arthritis
- Being tested
- Silastic Joint Replacement
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silastic Joint ReplacementProcedure or surgery
Participants who have had silastic joint replacement surgery for degenerative or inflammatory arthritis within the last three years
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start7 Apr 2022
- Primary completion5 Oct 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441462
- Sponsor's protocol ID
- PIPJ
- Status last verified
- Jun 2023
- First submitted
- 3 May 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining in Vivo Kinematics of Single Piece Silastic Joint Replacements in the Hand With Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05441462
- Acronym / sponsor ID
- PIPJ
- Conditions
- Degenerative Arthritis, Inflammatory Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess in vivo the kinematics of single piece silastic joint replacements in the hand with magnetic resonance imaging
Detailed description
Proximal inter phalangeal joint (PIPJ) replacement is performed for pain relief in the end stage of arthritis. Rheumatoid arthritis is the commonest indication in the metacarpophalangeal joint (MCPJ). In the PIPJ there is a more even spilt between degenerative and rheumatoid arthritis.
There are several options for PIPJ replacement currently licensed for use in the United Kingdom although data is not entered in to the National Joint Registry so the exact numbers and failure rates are unknown. Data from the Norwegian joint registry indicates that 99% of implanted MCPJ and PIPJ replacements are single piece silastic implants.
Three main prostheses represent the majority of implants used in the United Kingdom, Swanson, Sutter and Neuflex. All these implants have been shown in the literature to fracture either at the hinge or the distal stem - hinge interface. This is true of explants and in vitro simulator testing.
Long term survivorship in MCPJ and PIPJ replacement is below that of hip and knee replacement. One of the largest single series shows 63% survivorship at 17 year follow up but with radiological evidence of failure in at least two thirds. This compares poorly to the 82.9% survivorship for Exeter cemented hip replacements at 22 years. The long term aim of this project is to understand how the implants move. This will help explain failure in particular the newly observe hinge failure in Neuflex implants and provide ideas to improve these implants. Any modifications can be tested on the in vitro finger joint testing rig The method of MRI acquisition will be similar to that described in. This will require optimising. In order to limit movement to a sagittal displacement, a thermoplastic splint will support the wrist and hand up to the level of the proximal palmer crease. A rig will also be made to hold the MCP / PIP joints in extension and positions of flexion increasing by 200 to maximum flexion. These will depend upon the patient's range of motion. The Investigators will define the centre of rotation of the hinge then points on the shoulder and stem of the implant from which to measure displacement. Points on the metacarpal and proximal phalanx will also be defined to allow measurement of the displacement of the implant relative to the bone during the range of movement.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silastic Joint ReplacementParticipants who have had silastic joint replacement surgery for degenerative or inflammatory arthritis within the last three years | Procedure or surgery | – |
Primary outcome
Deformation Assesment - Assesment of deformation of single piece silastic joint replacements in vivo
Time frame: Six months
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.
1 secondary outcome
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.
Time frame: Through study completion, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Arthritis and Inflammatory Arthritis, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deformation Assesment - Assesment of deformation of single piece silastic joint replacements in vivo (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.