Regenerex Tibial Tray Multi-Center Data Collection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00859963

Enrollment

102

Registered

2009-03-11

Start date

2009-03-31

Completion date

2018-12-31

Last updated

2021-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Pain

Keywords

Press fit tibial tray

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Knee Society Score	5 years

Secondary

Measure	Time frame
Survivorship	5 years/ patient

Countries

United States

Outcome results