NCT00579059

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 7, 2009

Completed
Last Updated

July 17, 2017

Status Verified

June 1, 2017

Enrollment Period

3.5 years

First QC Date

December 17, 2007

Results QC Date

May 20, 2009

Last Update Submit

June 19, 2017

Conditions

OsteoarthritisRheumatoid ArthritisTraumatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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."

    1 Year

Secondary Outcomes (1)

  • Range of Motion - Flexion

    1 Year

Study Arms (2)

1

OTHER

Maxim® Pop-Top® Tibia

Device: Maxim® Knee System with Removable Molded Polyethylene Tibia

2

OTHER

Maxim® Regular Tibia

Device: Regular Maxim® Knee System

Interventions

Maxim® Knee System with Removable Molded Polyethylene TibiaDEVICE

Used for total knee replacements

Also known as: Maxim® Pop-Top® Tibia
1
Regular Maxim® Knee SystemDEVICE

Used for total knee replacements

Also known as: Modular Tibia
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomet Orthopedics, LLC

Warsaw, Indiana, 46581, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Study was terminated after enrollment failed to produce sufficient data to be analyzed.

Results Point of Contact

Title
Megan Lawson, Clinical Research Specialist
Organization
Biomet, LLC
megan.lawson@biomet.com
1-800-348-9500

Study Officials

  • Russell Wagner, MD

    Harris Methodist Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 21, 2007

Study Start

May 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

July 17, 2017

Results First Posted

July 7, 2009

Record last verified: 2017-06

Locations

US(1)