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

October 12, 2016 updated by: StelKast, Inc.
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 10 Years
10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

StelKast, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 344-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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