Clinical Indication for First Metatarsal Joint ArthrodesisTMTNCT02096146
TMT Fusion Plate vs. Two Crossed Screws
A study testing TMT Fusion plate and Two crossed screws in people with Clinical Indication for First Metatarsal Joint Arthrodesis, run by AO Clinical Investigation and Publishing Documentation at 5 sites in 3 countries.
Trial summary
This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly assigned to one of these two treatment options. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clinical Indication for First Metatarsal Joint Arthrodesis
- What is being tested?
- TMT Fusion plate and Two crossed screws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Oct 2014to Aug 2016
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: between 18 and 65 years
- At least one of the following:
- 1st TMT arthritis
- hallux valgus (intermetatarsal angle (IM) 1-2 angle > 15° on plain x-ray)
- 1st ray hypermobility with or without flat foot
- Painful condition
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- Ability to understand the content of the patient information / Informed Consent Form
- Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- Signed and dated IRB/EC-approved written informed consent
Who cannot join
- Active infection
- Previous surgery on the 1st ray of the same foot
- Previous non-union on the 1st ray of the same foot
- Clinical obvious arthritis in other joints of the lower extremities
- Purely seeking plastic surgery
- Peripheral vascular disease (e.g. advanced diabetes)
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- Peripheral sensory neuropathy (e.g. advanced diabetes)
- Concurrent surgery of the contralateral foot
- Any previously medically unmanaged severe systemic disease
- Substance abuse that would preclude reliable assessment
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Mid Michigan Orthopedic Institute - East Lansing
East Lansing, Michigan, 48823
NY Downtown Orthopedic Associates
New York, New York, 10038
Summit Orthopedics
Woodbury, Minnesota, 55125
About this study
Official title: TMT Fusion Plate vs. Two Crossed Screws - A Randomized Controlled Trial
This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly assigned to one of these two treatment options.
Read the detailed description
Tarsometatarsal joint arthrodesis is a common procedure which can be performed using various devices such as screws, plates or both. The Tarsometatarsal Fusion Plate from "DePuySynthes" is a new device designed to encourage bony fusion of the 1st TMT joint, and is expected to lead to earlier fusion compared to the current standard of care of using 2 crossed screws. This is expected, in turn, to result in an earlier reduction in pain and an earlier return to full activity. At this time there is insufficient data directly comparing outcome following surgery for patients treated with screws or plates, and a study protocol which produces a higher level of evidence is therefore necessary.
The main aim of this study is to compare patient-reported outcome following surgery for patients undergoing joint arthrodesis using the TMT Fusion plate versus screws only. It is expected that surgery will improve patient-reported outcome similarly for both treatment groups in the long-term, but that the improvement will occur earlier for the plate group. For this study patient-reported outcome will be assessed by the walking/standing and pain domain scores of the Manchester Oxford Foot Questionnaire (MOXFQ). An earlier improvement in any of these two domains would be considered to be valuable. The primary analysis will therefore compare the time to a minimal clinically relevant improvement for any of the two MOXFQ domains for patients treated with TMT fusion plate versus patients treated with only screws during the first 12 months following surgery.
An economic evaluation from a societal perspective will determine the incremental cost-effectiveness of the TMT fusion plate versus the 2 crossed screws technique for 1st TMT joint fusion. Therefore a randomized controlled trial will be conducted, where patient-reported outcomes as well as clinical outcome parameters will be assessed.
- Being tested
- TMT Fusion plate, Two crossed screws
- Keywords
- Plate, Hallux valgus, Foot deformity, Screw, Tarsometatarsal angle, Cost effectiveness
- Medical subject headings
- Hallux Valgus, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMT Fusion plateProcedure or surgery
Patients are treated with TMT Fusion Plate a post-market device to encourage bony fusion of the 1st TMT joint.
Two crossed screwsProcedure or surgery
Patients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion.
| Study group | Role | What they receive |
|---|---|---|
| TMT Fusion Plate | Other | Patients are treated with TMT Fusion Plate to encourage bony fusion of the 1st TMT joint. Receives: Procedure: TMT Fusion plate |
| Two crossed screws | Other | Patients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion . Receives: Procedure: Two crossed screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the patient-reported MOXFQ
Outcome measures for the study focus on fully validated patient related outcome measures for the foot (MOXFQ).
Measured: Up to 4 weeks pre-operative, Discharge (up to 1 week post-operative), 2 week FU, 6 week FU, 3 month FU, 6 month FU, 12 month FU
Secondary outcomes (6)
Development of bone healing assessed based on x-rays
Measured: 6 and 12 weeks postoperative
Reconstruction of the joint position based on x-rays
Measured: Pre-operative up to 4 weeks vs. post-operative up to 2 weeks
Change in quality of life (EQ-5D)
Outcome measure of general health
Measured: Up to 4 weeks pre-operative, discharge (up to 1 week post-op), 2 weeks FU, 6 weeks FU, 3 months FU, 6 months FU, 12 months FU
Weekly assessed weight bearing during weeks 6-12
Measured: 3 months FU
Complications related to implant or surgery
For the duration of the study complications are continuously recorded and not restricted to the defined follow up visits.
Measured: Starts with surgery and is continued until the end of the study (12 months FU)
Documentation of medication and treatment costs
A cost diary to collect treatment costs is distributed and collected at the next FU visit.
Measured: Starts after surgery and is continued until the end of the study (12 months FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Lack of enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Indication for First Metatarsal Joint ArthrodesisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Winson, MB ChB, FRCS, Principal investigator, Southmead Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096146
- Sponsor's protocol ID
- TMT Fusion Plate
- Acronym
- TMT
- Status last verified
- Aug 2020
- First submitted
- 21 Mar 2014
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMT Fusion Plate vs. Two Crossed Screws - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02096146
- Acronym / sponsor ID
- TMT / TMT Fusion Plate
- Keywords
- Plate, Hallux valgus, Foot deformity, Screw, Tarsometatarsal angle, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrolment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Mar 2014 (estimated)
- 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.
This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly assigned to one of these two treatment options.
Detailed description
Tarsometatarsal joint arthrodesis is a common procedure which can be performed using various devices such as screws, plates or both. The Tarsometatarsal Fusion Plate from "DePuySynthes" is a new device designed to encourage bony fusion of the 1st TMT joint, and is expected to lead to earlier fusion compared to the current standard of care of using 2 crossed screws. This is expected, in turn, to result in an earlier reduction in pain and an earlier return to full activity. At this time there is insufficient data directly comparing outcome following surgery for patients treated with screws or plates, and a study protocol which produces a higher level of evidence is therefore necessary.
The main aim of this study is to compare patient-reported outcome following surgery for patients undergoing joint arthrodesis using the TMT Fusion plate versus screws only. It is expected that surgery will improve patient-reported outcome similarly for both treatment groups in the long-term, but that the improvement will occur earlier for the plate group. For this study patient-reported outcome will be assessed by the walking/standing and pain domain scores of the Manchester Oxford Foot Questionnaire (MOXFQ). An earlier improvement in any of these two domains would be considered to be valuable. The primary analysis will therefore compare the time to a minimal clinically relevant improvement for any of the two MOXFQ domains for patients treated with TMT fusion plate versus patients treated with only screws during the first 12 months following surgery.
An economic evaluation from a societal perspective will determine the incremental cost-effectiveness of the TMT fusion plate versus the 2 crossed screws technique for 1st TMT joint fusion. Therefore a randomized controlled trial will be conducted, where patient-reported outcomes as well as clinical outcome parameters will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMT Fusion Plate | Other | Procedure: TMT Fusion platePatients are treated with TMT Fusion Plate to encourage bony fusion of the 1st TMT joint. |
| Two crossed screws | Other | Procedure: Two crossed screwsPatients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: between 18 and 65 years
- At least one of the following:
- Painful condition
- Ability to understand the content of the patient information / Informed Consent Form
- Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
Key exclusion criteria (12 listed)
- Active infection
- Previous surgery on the 1st ray of the same foot
- Previous non-union on the 1st ray of the same foot
- Clinical obvious arthritis in other joints of the lower extremities
- Purely seeking plastic 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 |
|---|---|---|
| TMT Fusion platePatients are treated with TMT Fusion Plate a post-market device to encourage bony fusion of the 1st TMT joint. | Procedure or surgery | TMT Fusion Plate |
| Two crossed screwsPatients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion. | Procedure or surgery | Two crossed screws |
Primary outcome
Change in the patient-reported MOXFQ
Time frame: Up to 4 weeks pre-operative, Discharge (up to 1 week post-operative), 2 week FU, 6 week FU, 3 month FU, 6 month FU, 12 month FU
Outcome measures for the study focus on fully validated patient related outcome measures for the foot (MOXFQ).
6 secondary outcomes
Development of bone healing assessed based on x-rays
Time frame: 6 and 12 weeks postoperative
Reconstruction of the joint position based on x-rays
Time frame: Pre-operative up to 4 weeks vs. post-operative up to 2 weeks
Change in quality of life (EQ-5D)
Time frame: Up to 4 weeks pre-operative, discharge (up to 1 week post-op), 2 weeks FU, 6 weeks FU, 3 months FU, 6 months FU, 12 months FU
Weekly assessed weight bearing during weeks 6-12
Time frame: 3 months FU
Complications related to implant or surgery
Time frame: Starts with surgery and is continued until the end of the study (12 months FU)
Documentation of medication and treatment costs
Time frame: Starts after surgery and is continued until the end of the study (12 months FU)
Results and safety
The study was stopped early (reason given: Lack of enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
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.
Ian Winson, MB ChB, FRCS principal investigator
Southmead Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMT Fusion plate and Two crossed screws in people with Clinical Indication for First Metatarsal Joint Arthrodesis, run by AO Clinical Investigation and Publishing Documentation at 5 sites in 3 countries.
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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Colombia, 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 was stopped early (reason given: Lack of enrolment). Results are not available in the source record.
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?
Change in the patient-reported MOXFQ (time frame: Up to 4 weeks pre-operative, Discharge (up to 1 week post-operative), 2 week FU, 6 week FU, 3 month FU, 6 month FU, 12 month FU). 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 13 Aug 2020.