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

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.

Study Overview

• Status: Terminated
• Conditions: Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System
• Intervention / Treatment: Device: Stelkast Surpass Acetabular System implant

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 Type: Observational
• Enrollment (Actual): 347

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Gill Orthopedic Clinic
  • Pennsylvania
    • Canonsburg, Pennsylvania, United States, 15317
      • Mutschler Orthopedic Institute
    • Glen Mills, Pennsylvania, United States, 19342
      • Premier Orthopedics and SPM Associates
    • Philadelphia, Pennsylvania, United States, 19107
      • The Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients treated with the Stelkast Surpass Acetabular System at the participating siteswill be included in the evaluation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stelkast Surpass Patients	Device: Stelkast Surpass Acetabular System implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survivorship	10 Years

Collaborators and Investigators

• Sponsor: StelKast, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (ESTIMATE): August 24, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Calcium Carbonate
• Other Study ID Numbers: 344-01