Rejuvenate Modular Outcomes Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2022-01-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rejuvenate Modular Hip System

Rejuvenate Modular Hip

Group Type OTHER

Rejuvenate Modular Hip

Intervention Type DEVICE

Rejuvenate Modular Hip

Interventions

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Rejuvenate Modular Hip

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No