A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System

Stryker Orthopaedics3 sites in 1 country42 target enrollmentNovember 2010

ConditionsArthroplasty, Replacement, Hip

Overview

Phase: N/A
Intervention: Not specified
Conditions: Arthroplasty, Replacement, Hip
Sponsor: Stryker Orthopaedics
Enrollment: 42
Locations: 3
Primary Endpoint: Survival Rate of the Rejuvenate Modular Stem/Neck
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

January 20, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stryker Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

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) ≥
•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.

Outcomes

Primary Outcomes

Survival Rate of the Rejuvenate Modular Stem/Neck

Time Frame: 5 years postoperative

The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.

Secondary Outcomes

Biomechanical Measurement of Femoral Offset(6 weeks)
Mean SF-12 Scores at Each Visit(pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year)
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)(6 wks,1,2,3,4,5 yrs)
Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation(6 weeks)
Mean Harris Hip Score at Each Visit(pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year)
Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit(pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year)
Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation(6 weeks)