Joint DiseaseMTTNCT00754637
Microplasty Tibial Tray Data Collection
An observational study of Joint Disease, run by Zimmer Biomet at 1 site in United States.
Trial summary
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients in need of relief frm painful or disabling Joint Disease, and meeting the 510(k) inclusion criteria on the cleared device.
Who may be able to join
- The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device in 510(k) K063732. These indications are stated below:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
- Patient selection factors to be considered include:
- Need to obtain pain relief and improve function
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- Ability and willingness of the patient to follow instructions, including control of weight and activity level
- A good nutritional state of the patient, and
- The patient must have reached full skeletal maturity
- Non-coated (Interlock®) devices are indicated for cemented application only.
Who cannot join
- The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device in 510(k) K063732. These contraindications are stated below:
- Absolute contraindications include: infection, sepsis, and osteomyelitis.
- Relative contraindications include:
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- Osteoporosis,
- Metabolic disorders which may impair bone formation,
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- Osteomalacia,
- Distant foci of infections which may spread to the implant site,
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
- Vascular insufficiency, muscular atrophy, neuromuscular disease,
- Incomplete or deficient soft tissue surrounding the knee.
- Biomet Microplasty™ Tibial Trays are contraindicated for use with constrained bearings.
Trial locations and contacts
1 site in 1 country.
United States1 site
The DeClaire Knee & Orthopaedic Institute
Rochester Hills, Michigan, 48307
About this study
Official title: Microplasty Tibial Tray Multi-Center Data Collection
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.
Read the detailed description
FDA has cleared this device via premarket notification 510(k) K063732. By being CE Marked, the Microplasty Tibial Tray also conforms to the essential requirements of EC Directive 93/42/EEC; in accordance to 13485:2003. The data gathered would be collated and used to provide feedback to design engineers, support marketing efforts, and answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K063732 Surgical techniques and patient care are to be standard for the surgeon participating in the protocol and should be maintained the same throughout the course of the data-collection. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling. Any use of the device or collection of clinical data outside of the United States should comply with all local, state, and/or national and international regulations.
Function will be assessed through the Knee Society Score . Survivorship will be documented by asking the surgeon to document revisions and complications.
- Conditions
- Joint Disease
- Keywords
- Joint, Osteoarthritis, Avascular Necrosis
- Medical subject headings
- Joint Diseases, Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 510(k) Inclusion Criteria | Any person meeting the inclusion criteria for the device may be included in this study. These patients tend to be those seeking relief from painful or debilitating knee joint disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Measured: 5 years
Secondary outcomes (1)
Radiographic Data
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startDec 2009
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: The study was withdrawn because it no longer fit the business need.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Joint DiseaseStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Beres, MD, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754637
- Sponsor's protocol ID
- 335
- Acronym
- MTT
- Status last verified
- Jun 2017
- First submitted
- 17 Sep 2008
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
PubMed 2805470Amstutz HC, Thomas BJ, Jinnah R, Kim W, Grogan T, Yale C. Treatment of primary osteoarthritis of the hip. A comparison of total joint and surface replacement arthroplasty. J Bone Joint Surg Am. 1984 Feb;66(2):228-41.
PubMed 6693450Brooks, et al. (Eds.). (2003) The Measurement and Valuation of Health Status Using EQ-5D: A European Perspective. Netherlands: Kluwer Academic Publishers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microplasty Tibial Tray Multi-Center Data Collection
- ClinicalTrials.gov ID
- NCT00754637
- Acronym / sponsor ID
- MTT / 335
- Conditions
- Joint Disease
- Keywords
- Joint, Osteoarthritis, Avascular Necrosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn because it no longer fit the business need.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 18 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.
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.
Detailed description
FDA has cleared this device via premarket notification 510(k) K063732. By being CE Marked, the Microplasty Tibial Tray also conforms to the essential requirements of EC Directive 93/42/EEC; in accordance to 13485:2003. The data gathered would be collated and used to provide feedback to design engineers, support marketing efforts, and answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K063732 Surgical techniques and patient care are to be standard for the surgeon participating in the protocol and should be maintained the same throughout the course of the data-collection. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling. Any use of the device or collection of clinical data outside of the United States should comply with all local, state, and/or national and international regulations.
Function will be assessed through the Knee Society Score . Survivorship will be documented by asking the surgeon to document revisions and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 510(k) Inclusion Criteria | – | –Any person meeting the inclusion criteria for the device may be included in this study. These patients tend to be those seeking relief from painful or debilitating knee joint disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of relief frm painful or disabling Joint Disease, and meeting the 510(k) inclusion criteria on the cleared device.
Key inclusion criteria (10 listed)
- The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device in 510(k) K063732. These indications are stated below:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
- Need to obtain pain relief and improve function
Key exclusion criteria (12 listed)
- The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device in 510(k) K063732. These contraindications are stated below:
- Absolute contraindications include: infection, sepsis, and osteomyelitis.
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- Osteoporosis,
- Metabolic disorders which may impair bone formation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knee Society Score
Time frame: 5 years
1 secondary outcome
Radiographic Data
Time frame: 10 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Background: PubMed 2805470Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
- Background: PubMed 6693450Amstutz HC, Thomas BJ, Jinnah R, Kim W, Grogan T, Yale C. Treatment of primary osteoarthritis of the hip. A comparison of total joint and surface replacement arthroplasty. J Bone Joint Surg Am. 1984 Feb;66(2):228-41.
- BackgroundBrooks, et al. (Eds.). (2003) The Measurement and Valuation of Health Status Using EQ-5D: A European Perspective. Netherlands: Kluwer Academic Publishers.
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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.
Ken Beres, MD study director
Zimmer Biomet
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 Joint Disease, run by Zimmer Biomet at 1 site 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 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: withdrawn, as of the sponsor's last update on 21 Jun 2017. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Knee Society Score (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754637, which also lists 3 linked publications.
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 2017.