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

Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01672086
• Other study ID #: 344-01
• Status: Terminated
• Phase: N/A
• First received: August 21, 2012
• Last updated: October 12, 2016
• Start date: August 2012
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: StelKast, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 347
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System

Intervention

Device:
• Stelkast Surpass Acetabular System implant

Locations

Country	Name	City	State
United States	Mutschler Orthopedic Institute	Canonsburg	Pennsylvania
United States	Gill Orthopedic Clinic	Charlotte	North Carolina
United States	Premier Orthopedics and SPM Associates	Glen Mills	Pennsylvania
United States	The Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
StelKast, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship		10 Years	No