Rejuvenate Modular Outcomes Study
This study is ongoing, but not recruiting participants.
Sponsor:
Stryker Orthopaedics
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01257568
First received: December 8, 2010
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
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.
| Condition |
|---|
|
Arthroplasty, Replacement, Hip |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System |
Resource links provided by NLM:
Further study details as provided by Stryker Orthopaedics:
Primary Outcome Measures:
- Survival Rate [ Time Frame: 5 years postoperative ] [ Designated as safety issue: No ]Evaluate the success rate of cementless primary THR with the Rejuvenate Modular Hip System as compared to the Secur-Fit HA monolithic femoral hip stem, through absence of revision at 5 years postoperative.
| Estimated Enrollment: | 240 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2022 |
| Estimated Primary Completion Date: | November 2022 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Rejuvenate Modular Hip System |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients eligible for Total Hip Replacement and meeting the Inclusion/Exclusion criteria at each investigative site will be invited to participate.
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) ≥ 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257568
Locations
| United States, Michigan | |
| Oakwood Healthcare | |
| Dearborn, Michigan, United States, 48124 | |
| United States, Minnesota | |
| St. Cloud Orthopaedics Associates | |
| Sartell, Minnesota, United States, 56377 | |
| United States, Oklahoma | |
| The Orthopedic Center | |
| Tulsa, Oklahoma, United States, 74104 | |
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
| Principal Investigator: | Yogesh Mittal, M.D. | The Orthopedic Center |
| Principal Investigator: | Joseph Nessler, M.D. | St. Cloud Orthopaedic Associates |
| Principal Investigator: | Lawrence Morawa, M.D. | Oakwood Healthcare System |
More Information
No publications provided
| Responsible Party: | Stryker Orthopaedics |
| ClinicalTrials.gov Identifier: | NCT01257568 History of Changes |
| Other Study ID Numbers: | 68 |
| Study First Received: | December 8, 2010 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013