Trials / Completed
CompletedNCT02362867
Balanced Knee System Clinical Protocol for IRB Approval
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (actual)
- Sponsor
- Ortho Development Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.
Detailed description
The rationale is based on the potential effectiveness of the BKS to: * Return patient to normal activities or increase mobility by restoring knee function. * Provide stability to enhance rehabilitation without external support. * Eliminate or reduce knee pain. * Assess the clinical efficacy after total knee replacement. * Determine implant survivorship and viability. * Evaluate patient function and satisfaction.
Conditions
- Osteoarthritis, Knee
- Rheumatoid Arthritis of Knee
- Post-traumatic Osteoarthritis of Knee Nos
- Valgus Deformity
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Balanced Knee System | A multi-compartmental total knee replacement providing a system of components for primary posterior cruciate ligament substituting procedures. The system consists of femoral, tibial, and patellar components that allow the surgeon to select the most appropriate component combination to meet specific patient needs. |
Timeline
- Start date
- 2003-01-01
- Primary completion
- 2019-06-02
- Completion
- 2019-06-02
- First posted
- 2015-02-13
- Last updated
- 2021-09-24
Source: ClinicalTrials.gov record NCT02362867. Inclusion in this directory is not an endorsement.