OsteoarthritisNCT00579059
Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia
A study testing Maxim® Knee System with Removable Molded Polyethylene Tibia and Regular Maxim® Knee System in people with Osteoarthritis and Rheumatoid Arthritis, run by Biomet Orthopedics, LLC at 1 site in United States.
Trial summary
The purpose of this prospective clinical data collection is to compare the outcomes of two different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- What is being tested?
- Maxim® Knee System with Removable Molded Polyethylene Tibia and Regular Maxim® Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Nov 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K991753,
- K984623, K993159, K010027). 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:
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- need to obtain pain relief and improve function,
- ability and willingness of the patient to follow instructions, including control of weight and activity level,
- a good nutritional state of the patient,
- the patient must have reached full skeletal maturity.
- Porous coated knee joint replacement prostheses have not been approved for non-cemented applications in the United States.
Who cannot join
- Identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K991753, K984623, K993159, K010027's). These contraindications are stated below:
- Absolute contraindications include:
- infection,
- sepsis
- osteomyelitis.
- Relative contraindications include:
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- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- Osteoporosis,
- metabolic disorders which may impair bone formation,
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System
The purpose of this prospective clinical data collection is to compare the outcomes of two different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia.
Read the detailed description
The purpose of this prospective clinical data collection is to document and compare the performance and clinical outcomes between the Maxim® Knee System with Removable Molded Poly Tibia and the Maxim® Knee System with Modular Tibial Bearing as two treatment groups.
FDA has cleared these devices via Premarket Notification 510(k)'s K991753, K984623, K993159, K010027. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts and answer potential questions from reimbursement agencies.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Being tested
- Maxim® Knee System with Removable Molded Polyethylene Tibia, Regular Maxim® Knee System
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxim® Knee System with Removable Molded Polyethylene TibiaDevice
Also called Maxim® Pop-Top® Tibia
Used for total knee replacements
Regular Maxim® Knee SystemDevice
Also called Modular Tibia
Used for total knee replacements
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Maxim® Pop-Top® Tibia Receives: Device: Maxim® Knee System with Removable Molded Polyethylene Tibia |
| 2 | Other | Maxim® Regular Tibia Receives: Device: Regular Maxim® Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Function Score
The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent," 60-89 is considered "Good," 30-59 is considered "fair," and 0-29 is considered "poor."
Measured: 1 Year
Secondary outcomes (1)
Range of Motion - Flexion
This represents how far the patients were able to flex the knee in the clinic at 1-year.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startMay 2004
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: The study sponsor canceled the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomet Orthopedics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Wagner, MD, Principal investigator, Harris Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579059
- Sponsor's protocol ID
- 62-U-007
- Status last verified
- Jun 2017
- First submitted
- 17 Dec 2007
- Last updated
- 17 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System
- ClinicalTrials.gov ID
- NCT00579059
- Acronym / sponsor ID
- 62-U-007
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study sponsor canceled the study.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 7 Jul 2009
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 compare the outcomes of two different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia.
Detailed description
The purpose of this prospective clinical data collection is to document and compare the performance and clinical outcomes between the Maxim® Knee System with Removable Molded Poly Tibia and the Maxim® Knee System with Modular Tibial Bearing as two treatment groups.
FDA has cleared these devices via Premarket Notification 510(k)'s K991753, K984623, K993159, K010027. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts and answer potential questions from reimbursement agencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Maxim® Knee System with Removable Molded Polyethylene TibiaMaxim® Pop-Top® Tibia |
| 2 | Other | Device: Regular Maxim® Knee SystemMaxim® Regular Tibia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K991753,
- 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 (14 listed)
- Identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K991753, K984623, K993159, K010027's). These contraindications are stated below:
- infection,
- sepsis
- osteomyelitis.
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
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 |
|---|---|---|
| Maxim® Knee System with Removable Molded Polyethylene TibiaAlso: Maxim® Pop-Top® TibiaUsed for total knee replacements | Device | 1 |
| Regular Maxim® Knee SystemAlso: Modular TibiaUsed for total knee replacements | Device | 2 |
Primary outcome
Knee Society Function Score
Time frame: 1 Year
The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent," 60-89 is considered "Good," 30-59 is considered "fair," and 0-29 is considered "poor."
1 secondary outcome
Range of Motion - Flexion
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Russell Wagner, MD principal investigator
Harris Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxim® Knee System with Removable Molded Polyethylene Tibia and Regular Maxim® Knee System in people with Osteoarthritis and Rheumatoid Arthritis, run by Biomet Orthopedics, LLC 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 11 inclusion and 14 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 17 Jul 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?
Yes. Results are posted in the registry (first posted 7 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Function Score (time frame: 1 Year). 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 17 Jul 2017.