Arthroplasty, Replacement, Hip
Conditions
Brief summary
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.
Interventions
DEVICERejuvenate Modular Hip
Rejuvenate Modular Hip
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate of the Rejuvenate Modular Stem/Neck | 5 years postoperative | The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation | 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. |
| Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation | 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. |
| Mean Harris Hip Score at Each Visit | 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 |
| Biomechanical Measurement of Femoral Offset | 6 weeks | Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters. |
| Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | 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. |
| Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | 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. |
| Mean SF-12 Scores at Each Visit | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Rejuvenate Modular Hip System All subjects who received the Rejuvenate Modular stem/neck. | 40 |
| Rejuvenate Modular Hip System All subjects who received the Rejuvenate Modular stem/neck. | 42 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Component Revision | 24 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Terminated | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Rejuvenate Modular Hip System |
|---|---|
| Age, Continuous Age | 62.50 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 40 |
| other Total, other adverse events | 9 / 42 | 7 / 40 |
| serious Total, serious adverse events | 25 / 42 | 4 / 40 |
Outcome results
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.
Time frame: 5 years postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rejuvenate Modular Hip System | Survival Rate of the Rejuvenate Modular Stem/Neck | 8 Surviving Hips |
Secondary
Biomechanical Measurement of Femoral Offset
Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.
Time frame: 6 weeks
Population: The data presented on these 41 hips is likely inaccurate due to issues and variations in data collection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rejuvenate Modular Hip System | Biomechanical Measurement of Femoral Offset | -2 mm |
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.
Time frame: 6 weeks
Population: The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rejuvenate Modular Hip System | Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation | 0 mm |
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.
Time frame: 6 weeks
Population: The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rejuvenate Modular Hip System | Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation | -4 mm |
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
Time frame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Population: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rejuvenate Modular Hip System | Mean Harris Hip Score at Each Visit | HHS Mean Preoperative Score | 55.48 units on a scale | Standard Deviation 9.88 |
| Rejuvenate Modular Hip System | Mean Harris Hip Score at Each Visit | HHS Mean 6 Week Score | 69.88 units on a scale | Standard Deviation 12.97 |
| Rejuvenate Modular Hip System | Mean Harris Hip Score at Each Visit | HHS Mean 1 Year Score | 94.25 units on a scale | Standard Deviation 7.65 |
| Rejuvenate Modular Hip System | Mean Harris Hip Score at Each Visit | HHS Mean 2 Year Score | 89.92 units on a scale | Standard Deviation 11.49 |
| Rejuvenate Modular Hip System | Mean Harris Hip Score at Each Visit | HHS Mean 3 Year Score | 90.83 units on a scale | Standard Deviation 11.71 |
| Rejuvenate Modular Hip System | Mean Harris Hip Score at Each Visit | HHS Mean 4 Year Score | 90.82 units on a scale | Standard Deviation 15.65 |
| Rejuvenate Modular Hip System | Mean Harris Hip Score at Each Visit | HHS Mean 5 Year Score | 97.88 units on a scale | Standard Deviation 2.1 |
| Rejuvenate Modular Hip System | Mean Harris Hip Score at Each Visit | HHS Mean 7 Year Score | 96.00 units on a scale | Standard Deviation 7.38 |
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.
Time frame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Population: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rejuvenate Modular Hip System | Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | Mean LEAS Score Preoperative | 8.88 units on a scale | Standard Deviation 2.58 |
| Rejuvenate Modular Hip System | Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | Mean LEAS Score 6 weeks | 7.45 units on a scale | Standard Deviation 1.53 |
| Rejuvenate Modular Hip System | Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | Mean LEAS Score 1 year | 11.32 units on a scale | Standard Deviation 3.05 |
| Rejuvenate Modular Hip System | Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | Mean LEAS Score 2 years | 11.18 units on a scale | Standard Deviation 3.06 |
| Rejuvenate Modular Hip System | Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | Mean LEAS Score 3 years | 11.85 units on a scale | Standard Deviation 2.76 |
| Rejuvenate Modular Hip System | Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | Mean LEAS Score 4 years | 11.29 units on a scale | Standard Deviation 2.93 |
| Rejuvenate Modular Hip System | Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | Mean LEAS Score 5 years | 13.33 units on a scale | Standard Deviation 3.14 |
| Rejuvenate Modular Hip System | Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit | Mean LEAS Score 7 years | 11.60 units on a scale | Standard Deviation 1.14 |
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.
Time frame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Population: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Mental Score 6 weeks | 54.35 units on a scale | Standard Deviation 9.37 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Mental Score 7 years | 58.84 units on a scale | Standard Deviation 2.68 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Physical Score Preoperative | 33.26 units on a scale | Standard Deviation 8.33 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Physical Score 6 weeks | 37.07 units on a scale | Standard Deviation 7.72 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Physical Score 1 year | 51.98 units on a scale | Standard Deviation 7.34 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Physical Score 2 years | 46.83 units on a scale | Standard Deviation 12.06 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Physical Score 3 years | 50.15 units on a scale | Standard Deviation 9.3 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Physical Score 4 years | 49.04 units on a scale | Standard Deviation 10.55 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Physical Score 5 years | 53.61 units on a scale | Standard Deviation 5.4 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Physical Score 7 years | 48.86 units on a scale | Standard Deviation 5.62 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Mental Score Preoperative | 51.6 units on a scale | Standard Deviation 13.48 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Mental Score 1 year | 55.01 units on a scale | Standard Deviation 9.26 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Mental Score 2 years | 53.99 units on a scale | Standard Deviation 10.13 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Mental Score 3 years | 54.47 units on a scale | Standard Deviation 10.03 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Mental Score 4 years | 48.77 units on a scale | Standard Deviation 10.99 |
| Rejuvenate Modular Hip System | Mean SF-12 Scores at Each Visit | Mean SF-12 Mental Score 5 years | 55.62 units on a scale | Standard Deviation 6.88 |
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.
Time frame: 6 wks,1,2,3,4,5 yrs
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Migration-1 year | 4 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Migration-5 years | 0 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Fixation Unstable-1 year | 1 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Radiographic stability-4 years | 9 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Radiographic stability-5 years | 4 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Subsidence-6 weeks | 5 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Migration-2 years | 4 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Migration-3 years | 6 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Migration-4 years | 4 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Fixation Unstable-2 years | 1 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Fixation Unstable-3 years | 0 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Fixation Unstable-4 years | 0 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Stem Fixation Unstable-5 years | 0 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Radiographic stability-6 weeks | 42 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Radiographic stability-1 year | 35 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Radiographic stability-2 years | 20 Hips |
| Rejuvenate Modular Hip System | Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) | Radiographic stability-3 years | 17 Hips |