Rejuvenate Modular Outcomes Study
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: December 8, 2010
Last updated: April 12, 2013
Last verified: April 2013
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.
Arthroplasty, Replacement, Hip
||Observational Model: Cohort
Time Perspective: Prospective
||A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2022 (Final data collection date for primary outcome measure)
Rejuvenate Modular Hip System
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients eligible for Total Hip Replacement and meeting the Inclusion/Exclusion criteria at each investigative site will be invited to participate.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257568
|Dearborn, Michigan, United States, 48124 |
|St. Cloud Orthopaedics Associates
|Sartell, Minnesota, United States, 56377 |
|The Orthopedic Center
|Tulsa, Oklahoma, United States, 74104 |
||Yogesh Mittal, M.D.
||The Orthopedic Center
||Joseph Nessler, M.D.
||St. Cloud Orthopaedic Associates
||Lawrence Morawa, M.D.
||Oakwood Healthcare System
No publications provided
ClinicalTrials.gov processed this record on December 10, 2013
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 8, 2010
||April 12, 2013
||United States: Institutional Review Board