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 12, 2013
Last verified: April 2013

December 8, 2010
April 12, 2013
November 2010
November 2022   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01257568 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients eligible for Total Hip Replacement and meeting the Inclusion/Exclusion criteria at each investigative site will be invited to participate.

Arthroplasty, Replacement, Hip
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Rejuvenate Modular Hip System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
November 2022
November 2022   (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01257568
68
No
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
April 2013

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