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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by StelKast, Inc.
Sponsor:
Information provided by (Responsible Party):
StelKast, Inc.
ClinicalTrials.gov Identifier:
NCT01672086
First received: August 21, 2012
Last updated: October 31, 2012
Last verified: October 2012
  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.:

Estimated Enrollment: 320
Study Start Date: August 2012
Estimated Study Completion Date: August 2022
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
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

Locations
United States, North Carolina
Gill Orthopedic Clinic Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Jennifer Hoffman       jlhoffman@novanthealth.org   
Principal Investigator: Lowell H Gill, MD         
United States, Pennsylvania
Orthopedic Specialists Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Cathy Levenite       clevenite@orthspec.com   
Principal Investigator: Robert P Good, MD         
Mutschler Orthopedic Institute Recruiting
Canonsburg, Pennsylvania, United States, 15317
Contact: Mary Ann Orlando       morlando@wpahs.org   
Principal Investigator: Thomas A Mutschler, MD         
Premier Orthopedics and SPM Associates Recruiting
Glen Mills, Pennsylvania, United States, 19342
Contact: Chrissy Bell       cbell@premierortho.com   
Principal Investigator: Frank P Giammattei, MD         
Sponsors and Collaborators
StelKast, Inc.
Investigators
Study Director: Abigail Allen Musculoskeletal Clinical Regulatory Advisers LLC
  More Information

No publications provided

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: October 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014