Rejuvenate Modular Outcomes Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Stryker Orthopaedics Identifier:
First received: December 8, 2010
Last updated: April 15, 2016
Last verified: April 2016
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: Yes ]
    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:
  • Biomechanical Measurements: Change in Femoral Offset and Center of Rotation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • SF-12 Scores at each visit [ Time Frame: pre-op, 6 wk, 1, 2, 3, 4, 5 year ] [ Designated as safety issue: No ]
  • Lower Extremity Activity Scale (LEAS) Scores at each visit [ Time Frame: pre-op, 6 wk, 1, 2, 3, 4, 5 year ] [ Designated as safety issue: No ]
  • Radiographic Stability: Stem Migration, Subsidence and Stem Fixation [ Time Frame: 6 wk, 1,2,3,4,5 yrs ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: November 2010
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2016 (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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01257568

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
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 Identifier: NCT01257568     History of Changes
Other Study ID Numbers: 68 
Study First Received: December 8, 2010
Last Updated: April 15, 2016
Health Authority: United States: Institutional Review Board processed this record on May 26, 2016