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

Terminated

• Conditions: Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System
• Interventions: Device: Stelkast Surpass Acetabular System implant

• Registration Number: NCT01672086
• Lead Sponsor: StelKast, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-24
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 347

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stelkast Surpass Patients	Stelkast Surpass Acetabular System implant	-

Primary Outcome Measures

Name	Time	Method
Survivorship	10 Years

Trial Locations

Locations (4)

The Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Gill Orthopedic Clinic; 🇺🇸 Charlotte, North Carolina, United States

Premier Orthopedics and SPM Associates; 🇺🇸 Glen Mills, Pennsylvania, United States

Mutschler Orthopedic Institute; 🇺🇸 Canonsburg, Pennsylvania, United States