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
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Condition or disease | Intervention/treatment |
---|---|
Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System | Device: Stelkast Surpass Acetabular System implant |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Stelkast Surpass Patients | Device: Stelkast Surpass Acetabular System implant |
- Survivorship [ Time Frame: 10 Years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
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 |
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 |