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Completed

NCT Number: NCT01257568

Rejuvenate Modular Outcomes Study

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oakwood Healthcare, Dearborn, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rejuvenate Modular Hip

Device

Rejuvenate Modular Hip

Primary outcomes

  1. Survival Rate of the Rejuvenate Modular Stem/Neck

    Time frame: 5 years postoperative

    The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.

Secondary outcomes

  1. Biomechanical Measurement of Femoral Offset

    Time frame: 6 weeks

    Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.

  2. Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation

    Time frame: 6 weeks

    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.

  3. Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation

    Time frame: 6 weeks

    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.

  4. Mean Harris Hip Score at Each Visit

    Time frame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year

    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

  5. Mean SF-12 Scores at Each Visit

    Time frame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year

    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.

  6. Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit

    Time frame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year

    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.

  7. Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)

    Time frame: 6 wks,1,2,3,4,5 yrs

    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.

Sponsors and collaborators

Lead sponsor

Stryker Orthopaedics

Industry

Registry information

Official study title

A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System

Important dates

Study start
2010
Primary completion
2017
Study completion
2022
First posted
Dec 9, 2010
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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