Trial Outcomes & Findings for Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study (NCT NCT01420237)

NCT ID: NCT01420237

Last Updated: 2025-01-22

Results Overview

Defined as absence of postoperative femoral head dislocation.

Recruitment status

TERMINATED

Study phase

Target enrollment

367 participants

Primary outcome timeframe

10 years postoperative

Results posted on

2025-01-22

Participant Flow

There were 390 hips in 367 participants that were enrolled in the study. (23 bilateral cases).

Of the 390 hips/367 participants enrolled there were 36 hips/34 participants censored due to not having the study device, surgery canceled or an inclusion exclusion violation so 354 hips/333 participants are followed who did receive the study device and met protocol criteria. Those applicable data are reflected in this record.

Unit of analysis: Hips

Participant milestones

Participant milestones
Measure	Restoration ADM X3 Device Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Overall Study STARTED	367 390
Overall Study Met Protocol Inclusion Criteria	333 354
Overall Study COMPLETED	67 70
Overall Study NOT COMPLETED	300 320

Reasons for withdrawal

Reasons for withdrawal
Measure	Restoration ADM X3 Device Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Overall Study Death	13
Overall Study Withdrawal by Subject	41
Overall Study Lost to Follow-up	32
Overall Study Adverse Event	10
Overall Study Investigative Site Termination	43
Overall Study Censored because study device not implanted	21
Overall Study Censored because surgery not performed	2
Overall Study Censored because of Inclusion Exclusion Violation	11
Overall Study Sponsor terminated study early	127

Baseline Characteristics

Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restoration ADM X3 Device n=333 Participants Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Age, Continuous Mean age	60.99 years n=5 Participants
Sex: Female, Male Female	164 Participants n=5 Participants
Sex: Female, Male Male	169 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	315 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 years postoperative

Population: Participants/hips with available data up to 10 years or at the time of early study termination.

Defined as absence of postoperative femoral head dislocation.

Outcome measures

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Success Rate	354 hips

SECONDARY outcome

Timeframe: pre-op, 6 week, 1,2,3,4,5 years. 7 and 10 years were optional.

Population: Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional.

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

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Harris Hip Score (HHS) Score Improvement From Preoperative Score Preoperative	54.47 score on a scale Standard Deviation 12.85
Harris Hip Score (HHS) Score Improvement From Preoperative Score 6 weeks	79.56 score on a scale Standard Deviation 14.03
Harris Hip Score (HHS) Score Improvement From Preoperative Score 2 years	92.99 score on a scale Standard Deviation 10.35
Harris Hip Score (HHS) Score Improvement From Preoperative Score 3 years	94.80 score on a scale Standard Deviation 9.00
Harris Hip Score (HHS) Score Improvement From Preoperative Score 4 years	94.22 score on a scale Standard Deviation 9.06
Harris Hip Score (HHS) Score Improvement From Preoperative Score 5 years	95.66 score on a scale Standard Deviation 6.69
Harris Hip Score (HHS) Score Improvement From Preoperative Score 7 years	93.77 score on a scale Standard Deviation 9.22
Harris Hip Score (HHS) Score Improvement From Preoperative Score 10 years	95.43 score on a scale Standard Deviation 7.67
Harris Hip Score (HHS) Score Improvement From Preoperative Score 1 year	92.32 score on a scale Standard Deviation 10.44

SECONDARY outcome

Timeframe: 10 years

Population: Includes all participants who received the study device and were not censored from analysis.

Revision or removal of any study component.

Outcome measures

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System	12 hips

SECONDARY outcome

Timeframe: 6-10 years

Population: Participants/hips with available data at the 6,7,8.9.10 years postoperative.

This questionnaire will be used to obtain the following information: * Satisfaction with the hip replacement * Presence of any pain in the study hip * Surgeries performed on the study hip * Any dislocations in the study hip

Outcome measures

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 8 years - Yes	0 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 8 years - No	129 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 9 years - Yes	8 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 9 years - No	73 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 9 years - Yes	79 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 9 years - No	1 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 9 years - Yes	0 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 9 years - No	80 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 9 years - Yes	0 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 9 years - No	80 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 10 years - Yes	8 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 10 years - No	62 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 10 years - Yes	69 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 10 years - No	1 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 10 years - Yes	1 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 10 years - No	69 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 10 years - Yes	0 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 10 years - No	70 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 6 years - Yes	25 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 6 years - No	172 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 6 years - Yes	191 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 6 years - No	4 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 6 years - Yes	0 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 6 years - No	197 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 6 years - Yes	0 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 6 years - No	197 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 7 years - Yes	22 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 7 years - No	141 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 7 years - Yes	162 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 7 years - No	1 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 7 years - Yes	0 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 7 years - No	163 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 7 years - Yes	0 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Any dislocations in the study hip at 7 years - No	163 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 8 years - Yes	128 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Satisfaction with the hip replacement at 8 years - No	1 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 8 years - Yes	0 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Surgeries performed on the study hip at 8 years - No	129 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 8 years - Yes	12 hips
Patient Satisfaction and Pain: Follow-up Questionnaire Presence of any pain in the study hip at 8 years - No	117 hips

SECONDARY outcome

Timeframe: 6 week,1, 2, 3, 4, 5 years

Population: Participants/hips with available radiographic data submitted at the outcome measure time frames.

Cases that present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones will be considered radiographic failures. All cases were assessed for any migration at the 6 week, 1,2,3,4,5 year time points.

Outcome measures

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Radiographic Stability Rates	0 hips

SECONDARY outcome

Timeframe: 10 years

Population: Participants/hips that reported an event of groin pain or psoas impingement up until early study termination.

Reported occurrence of any participant/hip experiencing groin pain or psoas impingement.

Outcome measures

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Complication Rates for Psoas Impingement and Associated Groin Pain	2 hips

SECONDARY outcome

Timeframe: preop, 6 week, 1,2,3,4,5 years

Population: Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional.

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

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Short Form-12 (SF-12) Improvement From Preoperative Score Pre-op Physical Component	32.62 score on a scale Standard Deviation 8.94
Short Form-12 (SF-12) Improvement From Preoperative Score 6 weeks Physical Component	40.02 score on a scale Standard Deviation 8.49
Short Form-12 (SF-12) Improvement From Preoperative Score 1-year Physical Component	48.43 score on a scale Standard Deviation 9.6
Short Form-12 (SF-12) Improvement From Preoperative Score 2-years Physical Component	49.44 score on a scale Standard Deviation 8.63
Short Form-12 (SF-12) Improvement From Preoperative Score 3-years Physical Component	49.69 score on a scale Standard Deviation 8.79
Short Form-12 (SF-12) Improvement From Preoperative Score 4-years Physical Component	48.93 score on a scale Standard Deviation 9.31
Short Form-12 (SF-12) Improvement From Preoperative Score 5-years Physical Component	48.49 score on a scale Standard Deviation 9.73
Short Form-12 (SF-12) Improvement From Preoperative Score 7-years Physical Component	48.45 score on a scale Standard Deviation 9.39
Short Form-12 (SF-12) Improvement From Preoperative Score 10-years Physical Component	49.26 score on a scale Standard Deviation 8.86
Short Form-12 (SF-12) Improvement From Preoperative Score Pre-op Mental Component	52.42 score on a scale Standard Deviation 10.99
Short Form-12 (SF-12) Improvement From Preoperative Score 6 weeks Mental Component	55.18 score on a scale Standard Deviation 9.33
Short Form-12 (SF-12) Improvement From Preoperative Score 1-year Mental Component	55.2 score on a scale Standard Deviation 7.61
Short Form-12 (SF-12) Improvement From Preoperative Score 2-years Mental Component	54.88 score on a scale Standard Deviation 7.8
Short Form-12 (SF-12) Improvement From Preoperative Score 3-years Mental Component	54.92 score on a scale Standard Deviation 7.69
Short Form-12 (SF-12) Improvement From Preoperative Score 4-years Mental Component	55.85 score on a scale Standard Deviation 6.95
Short Form-12 (SF-12) Improvement From Preoperative Score 5-years Mental Component	55.29 score on a scale Standard Deviation 7.81
Short Form-12 (SF-12) Improvement From Preoperative Score 7-years Mental Component	55.53 score on a scale Standard Deviation 7.94
Short Form-12 (SF-12) Improvement From Preoperative Score 10-years Mental Component	55.73 score on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: preop, 6 week, 1,2,3,4,5 years

Population: Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional.

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

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score Pre-op	9.2 score on a scale Standard Deviation 3.06
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score 6 weeks	8.94 score on a scale Standard Deviation 2.59
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score 1-year	11.49 score on a scale Standard Deviation 2.94
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score 2-years	11.79 score on a scale Standard Deviation 3.09
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score 3-years	11.82 score on a scale Standard Deviation 2.96
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score 4-years	11.66 score on a scale Standard Deviation 2.99
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score 5-years	11.62 score on a scale Standard Deviation 2.99
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score 7-years	11.3 score on a scale Standard Deviation 3.17
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score 10-years	10.84 score on a scale Standard Deviation 3.21

SECONDARY outcome

Timeframe: preop, 6 week, 1,2,3,4,5 years

Population: Participants/hips with available data. In addition to the outcome measure time frame detailed above, data is presented at 7 and 10 years, but these visits were optional.

The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health, and a high score shows better health.

Outcome measures

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
EQ-5D Index Score Improvement From Preoperative Score EQ-5D Pre-op	67.22 score on a scale Standard Deviation 19.16
EQ-5D Index Score Improvement From Preoperative Score EQ-5D 6 weeks	78.58 score on a scale Standard Deviation 15.53
EQ-5D Index Score Improvement From Preoperative Score EQ-5D 1-year	82.9 score on a scale Standard Deviation 13.76
EQ-5D Index Score Improvement From Preoperative Score EQ-5D 2-years	83.89 score on a scale Standard Deviation 13.14
EQ-5D Index Score Improvement From Preoperative Score EQ-5D 3-years	84.14 score on a scale Standard Deviation 12.29
EQ-5D Index Score Improvement From Preoperative Score EQ-5D 4-years	83.18 score on a scale Standard Deviation 12.54
EQ-5D Index Score Improvement From Preoperative Score EQ-5D 5-years	81.26 score on a scale Standard Deviation 14.63
EQ-5D Index Score Improvement From Preoperative Score EQ-5D 7-years	80.5 score on a scale Standard Deviation 16.21
EQ-5D Index Score Improvement From Preoperative Score EQ-5D 10-years	81.58 score on a scale Standard Deviation 21.09
EQ-5D Index Score Improvement From Preoperative Score E-5D TTO Pre-op	0.63 score on a scale Standard Deviation 0.19
EQ-5D Index Score Improvement From Preoperative Score EQ-5D TTO 6 weeks	0.81 score on a scale Standard Deviation 0.15
EQ-5D Index Score Improvement From Preoperative Score EQ-5D TTO 1-year	0.89 score on a scale Standard Deviation 0.13
EQ-5D Index Score Improvement From Preoperative Score EQ-5D TTO 2-years	0.90 score on a scale Standard Deviation 0.13
EQ-5D Index Score Improvement From Preoperative Score EQ-5D TTO 3-years	0.91 score on a scale Standard Deviation 0.13
EQ-5D Index Score Improvement From Preoperative Score EQ-5D TTO 4-years	0.9 score on a scale Standard Deviation 0.13
EQ-5D Index Score Improvement From Preoperative Score EQ-5D TTO 5-years	0.89 score on a scale Standard Deviation 0.15
EQ-5D Index Score Improvement From Preoperative Score EQ-5D TTO 7-years	0.9 score on a scale Standard Deviation 0.13
EQ-5D Index Score Improvement From Preoperative Score EQ-5D TTO 10-years	0.92 score on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: 10 years

Population: Participants/hips with available data at 10 years or at the time of early study termination. There were 12 hip revisions of the 354 hips in the study, leaving 342 hip cases without a revision of any components.

The number of hips that did not undergo a removal/revision of any of the hip components.

Outcome measures

Outcome measures
Measure	Restoration ADM X3 Device n=354 hips Restoration ADM X3 Device in total hip replacement. Restoration ADM X3 Device: Restoration ADM X3 Device in total hip replacement.
Percentage of Cases Which Did Not Have Any Component Revised	342 hips

Adverse Events

Operative Site Events

Serious events: 15 serious events

Other events: 56 other events

Deaths: 0 deaths

Non Operative Site Events

Serious events: 66 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Operative Site Events n=354 participants at risk All adverse events whether serious or not that occurred within the study population of 354 hips. These events are reported by unit/hip because in the case of bilateral participants (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 (by hip) for this reason.	Non Operative Site Events n=333 participants at risk All serious systemic adverse events that occurred in the study population of 333 participants.
Musculoskeletal and connective tissue disorders Operative site	15.8% 56/354 • Number of events 62 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Any AEs that meet the protocol defined reportable events must be reported from the time of consent through study completion (10 years) or in this case early study termination. Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Date of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.	— 0/0 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Any AEs that meet the protocol defined reportable events must be reported from the time of consent through study completion (10 years) or in this case early study termination. Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Date of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.

Additional Information

Kevin Barga, Senior Manager, Clinical Affairs

Stryker Orthopaedics

Phone: 201-831-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Each study investigator has independent publication privileges for their own center's results after multi-center publications are submitted. Sponsor requires review of publications. Sponsor shall not edit or influence the publications except to ensure that confidential information is not disclosed, no off-label device use is promoted, and that data is accurately represented. Any publications must be submitted to Stryker for review at least 60 days prior to submission of publication.
Publication restrictions are in place

Restriction type: OTHER