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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/CBCT)

NCT03231046

Hepatic Biopsy or Ablation

WITHDRAWN NA

Implementing Myocardial Computed Tomographic Perfusion in a Community Hospital Setting

NCT02756234

Coronary Artery Disease

COMPLETED

Becker Continued Access Study

NCT01286870

Breast Reconstruction

TERMINATED PHASE4

Placement of Novel Endoscopic Enteral Feeding Tube

NCT03520582

Healthy Volunteers Enteral Feeding

TERMINATED

PICC Asymptomatic Thrombosis Study: A Pilot Study

NCT04920929

Peripheral ICC

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stelkast Surpass Patients

Stelkast Surpass Acetabular System implant

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stelkast Surpass Acetabular System implant

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No