Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System

StelKast

Status: Terminated

Conditions: Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System

Treatments: Device: Stelkast Surpass Acetabular System implant

Study type: Observational

Funder types: Industry

Identifiers

NCT01672086

344-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 347 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

347 participants in 1 patient group

Stelkast Surpass Patients

Treatment:

Device: Stelkast Surpass Acetabular System implant