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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Rejuvenate Modular Hip

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Oakwood Healthcare
  • Minnesota
    • Sartell, Minnesota, United States, 56377
      • St. Cloud Orthopaedics Associates
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • The Orthopedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Rejuvenate Modular Hip System; Rejuvenate Modular Hip	Device: Rejuvenate Modular Hip; Rejuvenate Modular Hip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Rate of the Rejuvenate Modular Stem/Neck	The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.	5 years postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomechanical Measurement of Femoral Offset	Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.	6 weeks
Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation	Change from preoperative vertical distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.	6 weeks
Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation	Change from preoperative horizontal distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.	6 weeks
Mean Harris Hip Score at Each Visit	The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor	pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Mean SF-12 Scores at Each Visit	The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.	pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit	The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.	pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)	Radiographic stability of the stem is defined as having the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of great than or equal to 5 mm. Only subsidence was measured at 6 weeks, migration and fixation are analyzed beginning at 1 year postoperative.	6 wks,1,2,3,4,5 yrs

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): June 6, 2017
• Study Completion (ACTUAL): January 20, 2022

Study Registration Dates

• First Submitted: December 8, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (ESTIMATE): December 9, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 68