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

This study has been terminated.

(Product is no longer being manufactured and marketed.)

Sponsor:

ClinicalTrials.gov Identifier:

NCT01672086

First Posted: August 24, 2012

Last Update Posted: October 13, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

StelKast, Inc.

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:

Drug Information available for: Calcium carbonate

U.S. FDA Resources

Further study details as provided by StelKast, Inc.:

Primary Outcome Measures:

Survivorship [ Time Frame: 10 Years ]


Enrollment:	347
Study Start Date:	August 2012
Study Completion Date:	June 2016
Primary Completion Date:	June 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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.

Contacts and Locations

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

More Information


Responsible Party:	StelKast, Inc.
ClinicalTrials.gov Identifier:	NCT01672086 History of Changes
Other Study ID Numbers:	344-01
First Submitted:	August 21, 2012
First Posted:	August 24, 2012
Last Update Posted:	October 13, 2016
Last Verified:	October 2016

Additional relevant MeSH terms:


Calcium Carbonate Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents

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