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 30, 2014
Last verified: April 2014
  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 Intervention
Arthroplasty, Replacement, Hip
Device: Rejuvenate Modular Hip

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)
Arms Assigned Interventions
Rejuvenate Modular Hip System
Rejuvenate Modular Hip
Device: Rejuvenate Modular Hip
Rejuvenate Modular Hip

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 30, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 28, 2014