Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2015 |
Start Date: | August 2012 |
End Date: | August 2022 |
The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a
retrospective, multi-center, single-arm study intended to collect data on the survivorship
and long-term safety and effectiveness of the device.
retrospective, multi-center, single-arm study intended to collect data on the survivorship
and long-term safety and effectiveness of the device.
This active surveillance study is intended to evaluate the survivorship and long-term safety
and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the
surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the
survivorship observed in a historical control group established by a meta-analysis. The
evaluation will be conducted for a period of ten years. These evaluations will be recorded
through onsite visits and/or mailings sent to physicians requesting deidentified
patient-level data for subjects implanted with the Surpass system.
and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the
surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the
survivorship observed in a historical control group established by a meta-analysis. The
evaluation will be conducted for a period of ten years. These evaluations will be recorded
through onsite visits and/or mailings sent to physicians requesting deidentified
patient-level data for subjects implanted with the Surpass system.
Inclusion Criteria:
- Primary hip arthroplasty
- Skeletal maturity
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular
necrosis, congenital hip dysplasia, and traumatic arthritis
Exclusion Criteria:
- The Stelkast Surpass Acetabular System is contraindicated in patients with the
following conditions: Overt or latent infection in or around the hip joint,
insufficient bone stock to allow appropriate insertion and fixation of the
prosthesis, insufficient soft tissue integrity to provide adequate stability, muscle
laxity or inadequate soft tissue for proper function and healing, mental or
neuromuscular disorders that do not allow control of the affected joint, revision hip
arthroplasty, inflammatory hip joint disease, and neuropathic hip joint disease.
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