Clinical trial NCT00859963: Regenerex Tibial Tray Multi-Center Data Collection
Official title: Regenerex Tibial Tray Multi-Center Data Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Arthritis
Keywords: Press fit tibial tray
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2009-03-11
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients

Brief summary: The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the Regenerex™ Tibial Tray.

Detailed description: See Protocol

Eligibility criteria: Inclusion Criteria:

The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These indications are stated below:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, or arthrodesis.

Patient selection factors to be considered include:

1. Ability and willingness of the patient to follow instructions, including control of weight and activity level
2. A good nutritional state of the patient, and
3. The patient must have reached full skeletal maturity

Exclusion Criteria:

The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These contraindications are stated below:

* Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
* Relative contraindications include:

  1. Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  2. Osteoporosis,
  3. Metabolic disorders which may impair bone formation,
  4. Osteomalacia,
  5. Distant foci of infections which may spread to the implant site,
  6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
  7. Vascular insufficiency, muscular atrophy, neuromuscular disease,
  8. Incomplete or deficient soft tissue surrounding the knee.

Primary outcomes:
measure: Knee Society Score
timeFrame: 5 years
Secondary outcomes:
measure: Survivorship
timeFrame: 5 years/ patient
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, Department of Orthopedics
state: California
city: Chicago
country: United States
facility: Midwest Orthopedics at RUSH University
state: Illinois
city: Cedar Rapids
country: United States
facility: Physicians Clinic of Iowa
state: Iowa
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Virginia Beach
country: United States
facility: Jordan-Young Institute
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Jing Xie, PhD
role: STUDY_DIRECTOR
References: