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Rejuvenate Modular Outcomes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01257568
Recruitment Status : Active, not recruiting
First Posted : December 9, 2010
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Arthroplasty, Replacement, Hip Device: Rejuvenate Modular Hip

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
Study Start Date : November 2010
Primary Completion Date : June 6, 2017
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Rejuvenate Modular Hip System
Rejuvenate Modular Hip
Device: Rejuvenate Modular Hip
Rejuvenate Modular Hip


Outcome Measures

Primary Outcome Measures :
  1. Survival Rate [ Time Frame: 5 years postoperative ]
    Evaluate the success rate of cementless primary THR with the Rejuvenate Modular Hip System through absence of revision at 5 years postoperative.


Secondary Outcome Measures :
  1. Biomechanical Measurements: Change in Femoral Offset and Center of Rotation [ Time Frame: 6 weeks ]
    Change from preoperative plan and 6 week visit

  2. Harris Hip Score at each visit [ Time Frame: pre-op, 6 wk, 1, 2, 3, 4, 5 year ]
  3. SF-12 Scores at each visit [ Time Frame: pre-op, 6 wk, 1, 2, 3, 4, 5 year ]
  4. Lower Extremity Activity Scale (LEAS) Scores at each visit [ Time Frame: pre-op, 6 wk, 1, 2, 3, 4, 5 year ]
  5. Radiographic Stability: Stem Migration, Subsidence and Stem Fixation [ Time Frame: 6 wk, 1,2,3,4,5 yrs ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01257568     History of Changes
Other Study ID Numbers: 68
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: February 2017