Trial Outcomes & Findings for Rejuvenate Modular Outcomes Study (NCT NCT01257568)
NCT ID: NCT01257568
Last Updated: 2022-02-16
Results Overview
The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
5 years postoperative
Results posted on
2022-02-16
Participant Flow
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.
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.
Unit of analysis: Hips
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
40 42
|
|
Overall Study
COMPLETED
|
7 9
|
|
Overall Study
NOT COMPLETED
|
33 33
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Terminated
|
1
|
|
Overall Study
Component Revision
|
24
|
Baseline Characteristics
Rejuvenate Modular Outcomes Study
Baseline characteristics by cohort
| Measure |
Rejuvenate Modular Hip System
n=42 Hips
All subjects who received the Rejuvenate Modular stem/neck.
|
|---|---|
|
Age, Continuous
Age
|
62.50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 years postoperativeThe success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.
Outcome measures
| Measure |
Rejuvenate Modular Hip System
n=42 Hips
Rejuvenate Modular Hip
Rejuvenate Modular Hip: Rejuvenate Modular Hip
|
|---|---|
|
Survival Rate of the Rejuvenate Modular Stem/Neck
|
8 Surviving Hips
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The data presented on these 41 hips is likely inaccurate due to issues and variations in data collection.
Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.
Outcome measures
| Measure |
Rejuvenate Modular Hip System
n=41 Hips
Rejuvenate Modular Hip
Rejuvenate Modular Hip: Rejuvenate Modular Hip
|
|---|---|
|
Biomechanical Measurement of Femoral Offset
|
-2 mm
Interval -41.0 to 4.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection.
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.
Outcome measures
| Measure |
Rejuvenate Modular Hip System
n=5 Participants
Rejuvenate Modular Hip
Rejuvenate Modular Hip: Rejuvenate Modular Hip
|
|---|---|
|
Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation
|
-4 mm
Interval -38.0 to 1.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection.
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.
Outcome measures
| Measure |
Rejuvenate Modular Hip System
n=5 Participants
Rejuvenate Modular Hip
Rejuvenate Modular Hip: Rejuvenate Modular Hip
|
|---|---|
|
Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation
|
0 mm
Interval -2.0 to 2.0
|
SECONDARY outcome
Timeframe: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 yearPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
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
Outcome measures
| Measure |
Rejuvenate Modular Hip System
n=42 Hips
Rejuvenate Modular Hip
Rejuvenate Modular Hip: Rejuvenate Modular Hip
|
|---|---|
|
Mean Harris Hip Score at Each Visit
HHS Mean Preoperative Score
|
55.48 units on a scale
Standard Deviation 9.88
|
|
Mean Harris Hip Score at Each Visit
HHS Mean 6 Week Score
|
69.88 units on a scale
Standard Deviation 12.97
|
|
Mean Harris Hip Score at Each Visit
HHS Mean 1 Year Score
|
94.25 units on a scale
Standard Deviation 7.65
|
|
Mean Harris Hip Score at Each Visit
HHS Mean 2 Year Score
|
89.92 units on a scale
Standard Deviation 11.49
|
|
Mean Harris Hip Score at Each Visit
HHS Mean 3 Year Score
|
90.83 units on a scale
Standard Deviation 11.71
|
|
Mean Harris Hip Score at Each Visit
HHS Mean 4 Year Score
|
90.82 units on a scale
Standard Deviation 15.65
|
|
Mean Harris Hip Score at Each Visit
HHS Mean 5 Year Score
|
97.88 units on a scale
Standard Deviation 2.1
|
|
Mean Harris Hip Score at Each Visit
HHS Mean 7 Year Score
|
96.00 units on a scale
Standard Deviation 7.38
|
SECONDARY outcome
Timeframe: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 yearPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
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.
Outcome measures
| Measure |
Rejuvenate Modular Hip System
n=42 Hips
Rejuvenate Modular Hip
Rejuvenate Modular Hip: Rejuvenate Modular Hip
|
|---|---|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Physical Score Preoperative
|
33.26 units on a scale
Standard Deviation 8.33
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Physical Score 6 weeks
|
37.07 units on a scale
Standard Deviation 7.72
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Physical Score 1 year
|
51.98 units on a scale
Standard Deviation 7.34
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Physical Score 2 years
|
46.83 units on a scale
Standard Deviation 12.06
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Physical Score 3 years
|
50.15 units on a scale
Standard Deviation 9.3
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Physical Score 4 years
|
49.04 units on a scale
Standard Deviation 10.55
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Physical Score 5 years
|
53.61 units on a scale
Standard Deviation 5.4
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Physical Score 7 years
|
48.86 units on a scale
Standard Deviation 5.62
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Mental Score Preoperative
|
51.6 units on a scale
Standard Deviation 13.48
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Mental Score 6 weeks
|
54.35 units on a scale
Standard Deviation 9.37
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Mental Score 1 year
|
55.01 units on a scale
Standard Deviation 9.26
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Mental Score 2 years
|
53.99 units on a scale
Standard Deviation 10.13
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Mental Score 3 years
|
54.47 units on a scale
Standard Deviation 10.03
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Mental Score 4 years
|
48.77 units on a scale
Standard Deviation 10.99
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Mental Score 5 years
|
55.62 units on a scale
Standard Deviation 6.88
|
|
Mean SF-12 Scores at Each Visit
Mean SF-12 Mental Score 7 years
|
58.84 units on a scale
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 yearPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
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.
Outcome measures
| Measure |
Rejuvenate Modular Hip System
n=42 Hips
Rejuvenate Modular Hip
Rejuvenate Modular Hip: Rejuvenate Modular Hip
|
|---|---|
|
Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit
Mean LEAS Score Preoperative
|
8.88 units on a scale
Standard Deviation 2.58
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 6 wks,1,2,3,4,5 yrsPopulation: 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.
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.
Outcome measures
| Measure |
Rejuvenate Modular Hip System
n=42 Hips
Rejuvenate Modular Hip
Rejuvenate Modular Hip: Rejuvenate Modular Hip
|
|---|---|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Subsidence-6 weeks
|
5 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Migration-1 year
|
4 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Migration-2 years
|
4 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Migration-3 years
|
6 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Migration-4 years
|
4 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Migration-5 years
|
0 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Fixation Unstable-1 year
|
1 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Fixation Unstable-2 years
|
1 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Fixation Unstable-3 years
|
0 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Fixation Unstable-4 years
|
0 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Stem Fixation Unstable-5 years
|
0 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Radiographic stability-6 weeks
|
42 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Radiographic stability-1 year
|
35 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Radiographic stability-2 years
|
20 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Radiographic stability-3 years
|
17 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Radiographic stability-4 years
|
9 Hips
|
|
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Radiographic stability-5 years
|
4 Hips
|
Adverse Events
Operative Adverse Events
Serious events: 25 serious events
Other events: 9 other events
Deaths: 0 deaths
Non-Operative Adverse Events
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Operative Adverse Events
n=42 participants at risk
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.
|
Non-Operative Adverse Events
n=40 participants at risk
Rejuvenate Modular Stem/Neck. Non-operative site events are reported by participant.
|
|---|---|---|
|
Infections and infestations
Operative Site
|
2.4%
1/42 • Number of events 1 • 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.
|
—
0/0 • 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.
|
|
Injury, poisoning and procedural complications
Operative Site
|
2.4%
1/42 • Number of events 1 • 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.
|
—
0/0 • 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.
|
|
Musculoskeletal and connective tissue disorders
Operative Site
|
7.1%
3/42 • Number of events 3 • 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.
|
—
0/0 • 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.
|
|
Product Issues
Operative Site
|
52.4%
22/42 • Number of events 22 • 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.
|
—
0/0 • 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.
|
|
Cardiac disorders
Systemic Event
|
—
0/0 • 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.
|
2.5%
1/40 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Systemic Event
|
—
0/0 • 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.
|
2.5%
1/40 • Number of events 1 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systemic Event
|
—
0/0 • 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.
|
2.5%
1/40 • Number of events 1 • 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.
|
|
Nervous system disorders
Systemic Event
|
—
0/0 • 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.
|
2.5%
1/40 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Systemic Event
|
—
0/0 • 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.
|
2.5%
1/40 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Operative Adverse Events
n=42 participants at risk
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.
|
Non-Operative Adverse Events
n=40 participants at risk
Rejuvenate Modular Stem/Neck. Non-operative site events are reported by participant.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Operative Site
|
14.3%
6/42 • Number of events 6 • 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.
|
—
0/0 • 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.
|
|
Product Issues
Operative Event
|
9.5%
4/42 • Number of events 5 • 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.
|
—
0/0 • 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.
|
|
Product Issues
Systemic Events
|
—
0/0 • 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.
|
17.5%
7/40 • Number of events 7 • 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.
|
Additional Information
Shaherah Yancy, Director, Clinical Operations
Stryker Orthopaedics
Phone: 901-650-6601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER