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

Stopped early

Conditions studied: Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System

In brief

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.

Key facts

Study ID

NCT01672086

Run by

StelKast, Inc.

People needed

347

Starts

2012-08-01

Expected to finish

2016-06-01

Last updated by the study team

2016-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary hip arthroplasty
• Skeletal maturity
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis

You may not qualify if…

• 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.

Where it is running

• Gill Orthopedic Clinic — Charlotte, North Carolina, United States
• Mutschler Orthopedic Institute — Canonsburg, Pennsylvania, United States
• Premier Orthopedics and SPM Associates — Glen Mills, Pennsylvania, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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