ArthroplastyNCT00762944
Total Temporomandibular Joint Replacement System Post Approval Study
An observational study of Arthroplasty, run by Zimmer Biomet at 4 sites in United States.
Trial summary
Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data [PMA P020016] Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty
- What is being tested?
- Biomet TMJ Replacement System
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Sep 2005to 21 Sep 2008
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received TMJ systems from the IDE study
Who may be able to join
- Patients requiring total joint reconstruction due to:
- Arthritis (osteoarthritis, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints
- Patients who are skeletally mature.
- Patients must have at least one of the following criteria for surgical TMJ treatment.
- Presence of considerable pain and/or limited function in the joint area.
- Clinical and imaging evidence consistent with anatomic joint pathology
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- Previous failure of non-surgical treatment/therapy or a failed implant.
- High probability of patient improvement by surgical treatment.
- Patients must be able to return for follow-up examinations.
- Patients without serious compromising general medical conditions.
Who cannot join
- Patients with active infection.
- Patient conditions where there is insufficient quantity or quality of bone to support the device
- Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component.
- Patients with mandibular and/or zygomatic arch screw holes compromising component fixation
- Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication.
- Patients who are NOT skeletally mature.
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- Patients who are incapable or unwilling to follow postoperative care instructions.
- Patients who are unable to return for follow-up examinations.
- Patients with severe hyper-functional habits
- Patients on chronic steroid therapy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Texas,Southwestern Medical School
Dallas, Texas, 75390
Riley Hospital
Indianapolis, Indiana, 46202
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jeffrey S. Topf, D.D.S.
West Bloomfield, Michigan, 48322
About this study
Official title: Survivibility of the Total Temporomandibular Joint Replacement System
Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data [PMA P020016]
Read the detailed description
An additional three-year follow-up data will be collected on subjects previously enrolled in the PMA study, who had not completed follow-up prior to the PMA approval [PMA P020016].
- Conditions
- Arthroplasty
- Being tested
- Biomet TMJ Replacement System
- Keywords
- Patients requiring total joint reconstruction due to:, Arthritis (osteo-, rheumatoid, traumatic) malignancy, Ankylosis functional deformity, Avascular necrosis revisions, Benign neoplasms fracture, Multiple operated joints
- Medical subject headings
- Arthritis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomet TMJ Replacement SystemDevice
Also called TMJ alloplastic reconstruction
Total replacement of the temporomandibular joint with a Biomet TMJ Replacement System
| Study group | Role | What they receive |
|---|---|---|
| Biomet TMJ Replacement System | All patients required total reconstruction of the temporomandibular joint (unilateral or billateral) Receives: Device: Biomet TMJ Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Revision
Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal)
Measured: 3 years
Secondary outcomes (4)
jaw pain intensity (VAS score)
Pain level is recored in a 10 cm line according the intensity of pain, where zero on the far left represents "no pain" and 10 on the far right, represent the maximum level of pain experienced
Measured: 1 year, 1.5 years
Interference with eating
Interference of eating is recored in a 10 cm line according the intensity of the interference with eating, where zero on the far left represents "no interference with eating" and 10 on the far right, represent the maximum level of interference with eating experienced
Measured: 1 year, 1.5 years
Maximun Incisal Opening
Maximum Incisal Opening (MIO) is the distance measured in millimeters (mm) from the incisal edge of the maxillary central incisors to the incisal edge of the mandibular central incisors at the midline with the mouth wide open.
Measured: 1 year, 1.5 years
Patient Satisfaction
Patient satisfaction is the level of comfort with the TMJ reconstruction that a given patient experiences. It is expressed as "very satisfied", "satisfied", "dissatisfied" or "failure"
Measured: 6 months, 1 year, 1.5 years, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study start21 Sep 2005
- Primary completion25 Aug 2008
- Study completion21 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar A Gonzalez, MD, DNP, Study chair, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762944
- Sponsor's protocol ID
- BMET WL 01
- Status last verified
- Jun 2024
- First submitted
- 26 Sep 2008
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivibility of the Total Temporomandibular Joint Replacement System
- ClinicalTrials.gov ID
- NCT00762944
- Acronym / sponsor ID
- BMET WL 01
- Conditions
- Arthroplasty
- Keywords
- Patients requiring total joint reconstruction due to:, Arthritis (osteo-, rheumatoid, traumatic) malignancy, Ankylosis functional deformity, Avascular necrosis revisions, Benign neoplasms fracture, Multiple operated joints
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2005 (actual)
- Primary completion
- 25 Aug 2008 (actual)
- Study completion
- 21 Sep 2008 (actual)
- First posted
- 30 Sep 2008 (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.
Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data [PMA P020016]
Detailed description
An additional three-year follow-up data will be collected on subjects previously enrolled in the PMA study, who had not completed follow-up prior to the PMA approval [PMA P020016].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomet TMJ Replacement System | – | Device: Biomet TMJ Replacement SystemAll patients required total reconstruction of the temporomandibular joint (unilateral or billateral) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received TMJ systems from the IDE study
Key inclusion criteria (10 listed)
- Patients requiring total joint reconstruction due to:
- Arthritis (osteoarthritis, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints
- Patients who are skeletally mature.
- Patients must have at least one of the following criteria for surgical TMJ treatment.
- Patients must be able to return for follow-up examinations.
Key exclusion criteria (10 listed)
- Patients with active infection.
- Patient conditions where there is insufficient quantity or quality of bone to support the device
- Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component.
- Patients with mandibular and/or zygomatic arch screw holes compromising component fixation
- Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication.
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 |
|---|---|---|
| Biomet TMJ Replacement SystemAlso: TMJ alloplastic reconstructionTotal replacement of the temporomandibular joint with a Biomet TMJ Replacement System | Device | Biomet TMJ Replacement System |
Primary outcome
Time to Revision
Time frame: 3 years
Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal)
4 secondary outcomes
jaw pain intensity (VAS score)
Time frame: 1 year, 1.5 years
Interference with eating
Time frame: 1 year, 1.5 years
Maximun Incisal Opening
Time frame: 1 year, 1.5 years
Patient Satisfaction
Time frame: 6 months, 1 year, 1.5 years, and 3 years
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 21 Jun 2024.
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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.
Oscar A Gonzalez, MD, DNP study chair
Zimmer Biomet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, run by Zimmer Biomet at 4 sites in United States.
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 10 inclusion and 10 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Time to Revision (time frame: 3 years). 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 21 Jun 2024.