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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rejuvenate Modular Hip System | Other | Rejuvenate Modular Hip |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rejuvenate Modular Hip | Device | Rejuvenate Modular Hip |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakwood Healthcare | Dearborn | Michigan | 48124 | United States | ||
| St. Cloud Orthopaedics Associates |
42 participants/44 hips - 2 participants/2 hips censored = 40 participants/42 hips followed. There were 25 revisions, but one bilateral participant had one hip revised and the other hip completed the primary endpoint, this participant is counted as completed and not in the revision category.
Recruitment in the Rejuvenate Modular Hip Stem study was terminated early. Participants can have one or both hips replaced. If both hips were enrolled in the study and only one hip completed the primary endpoint the participant is counted as completed.
| ID | Title | Description |
|---|---|---|
| FG000 | Rejuvenate Modular Hip System | Participants who received the Rejuvenate Modular stem/neck can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Includes all participants who received the Rejuvenate Modular neck/stem and were not censored from analysis.
| ID | Title | Description |
|---|---|---|
| BG000 | Rejuvenate Modular Hip System | All subjects who received the Rejuvenate Modular stem/neck. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For bilateral participants, age at the time of surgery for the first hip enrolled is used for the baseline measurement |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Surviving Hips | 5 years postoperative | Hips | Hips |
|
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To 10 years postoperative. All AEs that meet the definition of serious, excluding elective procedures, and all AEs related to the operative site, regardless of seriousness.
Censored were not included as at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Operative Adverse Events | Rejuvenate Modular Stem/Neck. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Primary Outcome Note: Due to the large number of terminations and halting enrollment early in the study, the primary endpoint analysis will not be performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaherah Yancy, Director, Clinical Operations | Stryker Orthopaedics | 901-650-6601 | shaherah.yancy@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 7, 2009 | Apr 26, 2018 | Prot_SAP_ICF_000.pdf |
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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 |
| Sartell |
| Minnesota |
| 56377 |
| United States |
| The Orthopedic Center | Tulsa | Oklahoma | 74104 | United States |
| Component Revision |
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| Hips |
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| Mean |
| Full Range |
| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| Hips |
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| Secondary | Biomechanical Measurement of Femoral Offset | Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters. | The data presented on these 41 hips is likely inaccurate due to issues and variations in data collection. | Posted | Median | Inter-Quartile Range | mm | 6 weeks | Hips | Hips |
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| Secondary | 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. | The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection. | Posted | Median | Inter-Quartile Range | mm | 6 weeks |
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| Secondary | 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. | The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection. | Posted | Median | Inter-Quartile Range | mm | 6 weeks |
|
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| Secondary | 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 | Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year | Hips | Hips |
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| Secondary | 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. | Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year | Hips | Hips |
|
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| Secondary | 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. | Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year | Hips | Hips |
|
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| Secondary | 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. | Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population. The number of hips analyzed for stem subsidence equals the number of cases with a readable AP Femur or Pelvis x-ray. | Posted | Number | Hips | 6 wks,1,2,3,4,5 yrs | Hips | Hips |
|
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| 0 |
| 42 |
| 25 |
| 42 |
| 9 |
| 42 |
| EG001 | Non-Operative Adverse Events | Rejuvenate Modular Stem/Neck. Non-operative site events are reported by participant. | 0 | 40 | 4 | 40 | 7 | 40 |
| Operative Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Operative Site | Product Issues | Non-systematic Assessment |
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| Systemic Event | Cardiac disorders | Non-systematic Assessment |
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| Systemic Event | Gastrointestinal disorders | Non-systematic Assessment |
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| Systemic Event | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Systemic Event | Nervous system disorders | Non-systematic Assessment |
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| Systemic Event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Operative Event | Product Issues | Non-systematic Assessment |
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| Systemic Events | Product Issues | Non-systematic Assessment |
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Each investigator shall have privileges for their own center's results. These manuscripts and abstracts will be delayed until after the 5-year multi-center publication is submitted. All publications shall be submitted to the sponsor for review at least 60 days prior to submission for publication. The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.
| HHS Mean 6 Week Score |
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| HHS Mean 1 Year Score |
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| HHS Mean 2 Year Score |
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| HHS Mean 3 Year Score |
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| HHS Mean 4 Year Score |
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| HHS Mean 5 Year Score |
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| HHS Mean 7 Year Score |
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| Mean SF-12 Physical Score 6 weeks |
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| Mean SF-12 Physical Score 1 year |
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| Mean SF-12 Physical Score 2 years |
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| Mean SF-12 Physical Score 3 years |
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| Mean SF-12 Physical Score 4 years |
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| Mean SF-12 Physical Score 5 years |
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| Mean SF-12 Physical Score 7 years |
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| Mean SF-12 Mental Score Preoperative |
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| Mean SF-12 Mental Score 6 weeks |
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| Mean SF-12 Mental Score 1 year |
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| Mean SF-12 Mental Score 2 years |
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| Mean SF-12 Mental Score 3 years |
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| Mean SF-12 Mental Score 4 years |
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| Mean SF-12 Mental Score 5 years |
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| Mean SF-12 Mental Score 7 years |
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| Mean LEAS Score 6 weeks |
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| Mean LEAS Score 1 year |
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| Mean LEAS Score 2 years |
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| Mean LEAS Score 3 years |
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| Mean LEAS Score 4 years |
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| Mean LEAS Score 5 years |
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| Mean LEAS Score 7 years |
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| Stem Migration-1 year |
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| Stem Migration-2 years |
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| Stem Migration-3 years |
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| Stem Migration-4 years |
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| Stem Migration-5 years |
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| Stem Fixation Unstable-1 year |
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| Stem Fixation Unstable-2 years |
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| Stem Fixation Unstable-3 years |
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| Stem Fixation Unstable-4 years |
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| Stem Fixation Unstable-5 years |
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| Radiographic stability-6 weeks |
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| Radiographic stability-1 year |
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| Radiographic stability-2 years |
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| Radiographic stability-3 years |
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| Radiographic stability-4 years |
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| Radiographic stability-5 years |
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