Rejuvenate Modular Outcomes Study

Stryker

Status

Completed

Conditions

Arthroplasty, Replacement, Hip

Treatments

Device: Rejuvenate Modular Hip

Study type

Interventional

Funder types

Industry

Identifiers

NCT01257568

Details and patient eligibility

About

This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years and clinical outcomes for up to 10 years after surgery.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has signed an IRB approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
Patient is a candidate for a primary cementless total hip replacement.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Patient's operative femur templates to Rejuvenate® Modular Stem size 7-12.

Exclusion criteria

Patient has a Body Mass Index (BMI) ≥ 40.
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, which limits the ability to evaluate the safety and efficacy of the device.
Patient 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 requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
Patient has a known sensitivity to device materials.
Patient is a prisoner.