Secur-Fit Advanced Outcomes Study

Stryker

Status

Terminated

Conditions

Arthroplasty, Replacement, Hip

Treatments

Device: Secur-Fit Advanced Hip Stem

Study type

Interventional

Funder types

Industry

Identifiers

NCT01917929

Details and patient eligibility

About

The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.

Full description

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a cementless application in a consecutive series of patients who meet the eligibility criteria.

The primary objective of this study is to evaluate the success rate of cementless primary total hip replacement with the Secur-Fit Advanced Hip Stem. Success will be defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture at 5 years postoperative. It is expected that the success rate of the Secur-Fit Advanced Hip Stem group will be non-inferior to the selected reference rate of 99% at 5 years postoperative.

Enrollment

326 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female, skeletally mature and age 21-75 years at time of study device implantation.
Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease.
Patient is a candidate for primary total hip arthroplasty.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion criteria

Patient has previously undergone open surgical intervention on the operative hip.
Patient has a prior femoral fracture, with or without deformity, on the operative side.
Patient has an existing total hip replacement on the contralateral side.
Patient requires simultaneous bilateral total hip replacement.
Patient has a Body Mass Index (BMI) > 45.
Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
Patient has a neuromuscular or neurosensory deficiency that would create an unacceptable risk of instability, prosthesis fixation failure or complications in postoperative care, or which limits the ability to evaluate the safety and efficacy of the device.
Patient has bone stock that is inadequate for support or fixation of the prosthesis, or is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
Patient has a known sensitivity to device materials.
Patient is a prisoner.