Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System
This study is ongoing, but not recruiting participants.
Sponsor:
StelKast, Inc.
Information provided by (Responsible Party):
StelKast, Inc.
ClinicalTrials.gov Identifier:
NCT01672086
First received: August 21, 2012
Last updated: November 17, 2014
Last verified: November 2014
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Purpose
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 | Intervention |
|---|---|
|
Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System |
Device: Stelkast Surpass Acetabular System implant |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System |
Resource links provided by NLM:
Further study details as provided by StelKast, Inc.:
Primary Outcome Measures:
- Survivorship [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 320 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2022 |
| Estimated Primary Completion Date: | August 2022 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Stelkast Surpass Patients | 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672086
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | StelKast, Inc. |
| ClinicalTrials.gov Identifier: | NCT01672086 History of Changes |
| Other Study ID Numbers: | 344-01 |
| Study First Received: | August 21, 2012 |
| Last Updated: | November 17, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Calcium Carbonate Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 23, 2016