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

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ClinicalTrials.gov Identifier: NCT01672086
Recruitment Status : Terminated (Product is no longer being manufactured and marketed.)
First Posted : August 24, 2012
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System 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
Actual Enrollment : 347 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System
Study Start Date : August 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Survivorship [ Time Frame: 10 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672086


Locations
United States, North Carolina
Gill Orthopedic Clinic
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
Mutschler Orthopedic Institute
Canonsburg, Pennsylvania, United States, 15317
Premier Orthopedics and SPM Associates
Glen Mills, Pennsylvania, United States, 19342
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
StelKast, Inc.
Investigators
Study Director: Abigail Allen Musculoskeletal Clinical Regulatory Advisers

Responsible Party: StelKast, Inc.
ClinicalTrials.gov Identifier: NCT01672086     History of Changes
Other Study ID Numbers: 344-01
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents