Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Warsaw, Indiana 46581


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 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: - 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. Exclusion Criteria: 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: - 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.


Study is Available At:


Original ID:

62-U-007


NCT ID:

NCT00579059


Secondary ID:


Study Acronym:


Brief Title:

Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia


Official Title:

A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Biomet, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

The study sponsor canceled the study.


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

31


Enrollment Type:

Actual


Overall Contact Information

Official Name:Russell Wagner, MD
Principal Investigator
Harris Methodist Hospital

Study Dates

Start Date:May 2004
Completion Date:November 2007
Completion Type:Actual
Primary Completion Date:November 2007
Primary Completion Type:Actual
Verification Date:February 2012
Last Changed Date:February 29, 2012
First Received Date:December 17, 2007
First Results Date:May 20, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Range of Motion - Flexion
Time Frame:1 Year
Safety Issues:False
Description:This represents how far the patients were able to flex the knee in the clinic at 1-year.
Outcome Type:Primary Outcome
Measure:Knee Society Function Score
Time Frame:1 Year
Safety Issues:False
Description: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."

Study Interventions

Intervention Type:Device
Name:Maxim® Knee System with Removable Molded Polyethyl
Description:Used for total knee replacements
Arm Name:1
Other Name:Maxim® Pop-Top® Tibia
Intervention Type:Device
Name:Regular Maxim® Knee System
Description:Used for total knee replacements
Arm Name:2
Other Name:Modular Tibia

Study Arms

Study Arm Type:Other
Arm Name:2
Description:Maxim® Regular Tibia
Study Arm Type:Other
Arm Name:1
Description:Maxim® Pop-Top® Tibia

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Biomet Orthopedics, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.