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Rejuvenate Modular Outcomes Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01257568
First received: December 8, 2010
Last updated: April 19, 2017
Last verified: February 2017

December 8, 2010
April 19, 2017
November 2010
May 12, 2017   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01257568 on ClinicalTrials.gov Archive Site
  • Biomechanical Measurements: Change in Femoral Offset and Center of Rotation [ Time Frame: 6 weeks ]
    Change from preoperative plan and 6 week visit
  • Harris Hip Score at each visit [ Time Frame: pre-op, 6 wk, 1, 2, 3, 4, 5 year ]
  • SF-12 Scores at each visit [ Time Frame: pre-op, 6 wk, 1, 2, 3, 4, 5 year ]
  • Lower Extremity Activity Scale (LEAS) Scores at each visit [ Time Frame: pre-op, 6 wk, 1, 2, 3, 4, 5 year ]
  • Radiographic Stability: Stem Migration, Subsidence and Stem Fixation [ Time Frame: 6 wk, 1,2,3,4,5 yrs ]
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Rejuvenate Modular Outcomes Study
A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Arthroplasty, Replacement, Hip
Device: Rejuvenate Modular Hip
Rejuvenate Modular Hip
Rejuvenate Modular Hip System
Rejuvenate Modular Hip
Intervention: Device: Rejuvenate Modular Hip
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
44
December 2021
May 12, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01257568
68
No
Not Provided
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Stryker Orthopaedics
Stryker Orthopaedics
Not Provided
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
Stryker Orthopaedics
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP