Clinical trial NCT00579059: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Knee Society Function Score
timeFrame: 1 Year
Secondary outcomes:
measure: Range of Motion - Flexion
timeFrame: 1 Year
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: Biomet Orthopedics, LLC
state: Indiana
Study officials:
affiliation: Harris Methodist Hospital
name: Russell Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References: