TerminatedNCT01420237Updated Jan 22, 2025Results posted

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

An interventional study of Restoration ADM X3 Device in Arthroplasty, Replacement, Hip, sponsored by Stryker Orthopaedics. Terminated at 12 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Stryker Orthopaedics · Not applicable, Interventional, and Treatment

Why this study was terminated

As longitudinal patient follow-up continues to lag, it has been determined that the study is no longer able to meet its objectives.

Phase: Not applicable
Study type: Interventional
Enrollment: 367
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study summary

The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip systems in the literature, through absence of femoral head dislocation at 10 years postoperative.

Read the detailed description

This study is a prospective, open-label, post-market, non-randomized, multi-center, clinical evaluation of the Restoration® ADM X3® Acetabular System for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is 350 cases, all of which will receive the Restoration® ADM X3® Acetabular System. A minimum of 100 cases (within the study population) will receive the Accolade® II Hip Stem. The remaining cases will receive any other compatible Stryker femoral component.

Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.

Conditions studied

Arthroplasty, Replacement, Hip

Keywords

Noninflammatory joint disease of the hip.

In context

Lead sponsor

Stryker Orthopaedics is the lead sponsor of 44 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patient has signed an IRB/EC approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female, skeletally mature and age 18-75 years at time of study device implantation.
Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
Patient is a candidate for a primary cementless acetabular replacement.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion criteria

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 367 participants (actual)

Study arms

Other
Restoration ADM X3 Device
Restoration ADM X3 Device in total hip replacement.
Device: Restoration ADM X3 Device

Interventions

DeviceRestoration ADM X3 Device
Restoration ADM X3 Device in total hip replacement.

What researchers measure

Primary outcomes

Success Rate
Defined as absence of postoperative femoral head dislocation.
Time frame: 10 years postoperative

Secondary outcomes

Harris Hip Score (HHS) Score Improvement From Preoperative Score
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 week, 1,2,3,4,5 years. 7 and 10 years were optional.
All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System
Revision or removal of any study component.
Time frame: 10 years
Patient Satisfaction and Pain: Follow-up Questionnaire
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
Time frame: 6-10 years
Radiographic Stability Rates
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.
Time frame: 6 week,1, 2, 3, 4, 5 years
Complication Rates for Psoas Impingement and Associated Groin Pain
Reported occurrence of any participant/hip experiencing groin pain or psoas impingement.
Time frame: 10 years
Short Form-12 (SF-12) Improvement From Preoperative Score
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: preop, 6 week, 1,2,3,4,5 years
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score
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: preop, 6 week, 1,2,3,4,5 years
EQ-5D Index Score Improvement From Preoperative Score
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.
Time frame: preop, 6 week, 1,2,3,4,5 years
Percentage of Cases Which Did Not Have Any Component Revised
The number of hips that did not undergo a removal/revision of any of the hip components.
Time frame: 10 years

Results

Posted Jan 22, 2025

Limitations and caveats

Due to circumstances starting with the COVID-19 pandemic and challenges recalling study subjects for long term postoperative visits, the follow-up compliance decreased significantly. Therefore, there would be inadequate subjects to analyze at the 10 year endpoint. For this reason, a business decision was made to close the study early.

Participant flow

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

Participant flow — Overall Study
Milestone	Restoration ADM X3 Device
Started	367
Met protocol inclusion criteria	333
Completed	67
Not completed	300
Withdrew: Death	13
Withdrew: Withdrawal by subject	41
Withdrew: Lost to follow-up	32
Withdrew: Adverse event	10
Withdrew: Investigative site termination	43
Withdrew: Censored because study device not implanted	21
Withdrew: Censored because surgery not performed	2
Withdrew: Censored because of inclusion exclusion violation	11
Withdrew: Sponsor terminated study early	127

Outcome measures

PrimarySuccess Rate

Defined as absence of postoperative femoral head dislocation.

Time frame:: 10 years postoperative
Reported as:: Number · hips

Success Rate
hips	Restoration ADM X3 Device
Success Rate	354

SecondaryHarris Hip Score (HHS) Score Improvement From Preoperative Score

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 week, 1,2,3,4,5 years. 7 and 10 years were optional.
Reported as:: Mean · score on a scale

Harris Hip Score (HHS) Score Improvement From Preoperative Score
score on a scale	Restoration ADM X3 Device
Preoperative	54.47 ± 12.85
6 weeks	79.56 ± 14.03
1 year	92.32 ± 10.44
2 years	92.99 ± 10.35
3 years	94.80 ± 9.00
4 years	94.22 ± 9.06
5 years	95.66 ± 6.69
7 years	93.77 ± 9.22
10 years	95.43 ± 7.67

SecondaryAll Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System

Revision or removal of any study component.

Time frame:: 10 years
Reported as:: Number · hips

All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System
hips	Restoration ADM X3 Device
All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System	12

SecondaryPatient Satisfaction and Pain: Follow-up Questionnaire

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

Time frame:: 6-10 years
Reported as:: Count of units · hips

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

SecondaryRadiographic Stability Rates

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.

Time frame:: 6 week,1, 2, 3, 4, 5 years
Reported as:: Number · hips

Radiographic Stability Rates
hips	Restoration ADM X3 Device
Radiographic Stability Rates	0

SecondaryComplication Rates for Psoas Impingement and Associated Groin Pain

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

Time frame:: 10 years
Reported as:: Number · hips

Complication Rates for Psoas Impingement and Associated Groin Pain
hips	Restoration ADM X3 Device
Complication Rates for Psoas Impingement and Associated Groin Pain	2

SecondaryShort Form-12 (SF-12) Improvement From Preoperative Score

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:: preop, 6 week, 1,2,3,4,5 years
Reported as:: Mean · score on a scale

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

SecondaryLower Extremity Activity Scale (LEAS) Improvement From Preoperative Score

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:: preop, 6 week, 1,2,3,4,5 years
Reported as:: Mean · score on a scale

Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score
score on a scale	Restoration ADM X3 Device
Pre-op	9.2 ± 3.06
6 weeks	8.94 ± 2.59
1-year	11.49 ± 2.94
2-years	11.79 ± 3.09
3-years	11.82 ± 2.96
4-years	11.66 ± 2.99
5-years	11.62 ± 2.99
7-years	11.3 ± 3.17
10-years	10.84 ± 3.21

SecondaryEQ-5D Index Score Improvement From Preoperative Score

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.

Time frame:: preop, 6 week, 1,2,3,4,5 years
Reported as:: Mean · score on a scale

EQ-5D Index Score Improvement From Preoperative Score
score on a scale	Restoration ADM X3 Device
EQ-5D Pre-op	67.22 ± 19.16
EQ-5D 6 weeks	78.58 ± 15.53
EQ-5D 1-year	82.9 ± 13.76
EQ-5D 2-years	83.89 ± 13.14
EQ-5D 3-years	84.14 ± 12.29
EQ-5D 4-years	83.18 ± 12.54
EQ-5D 5-years	81.26 ± 14.63
EQ-5D 7-years	80.5 ± 16.21
EQ-5D 10-years	81.58 ± 21.09
E-5D TTO Pre-op	0.63 ± 0.19
EQ-5D TTO 6 weeks	0.81 ± 0.15
EQ-5D TTO 1-year	0.89 ± 0.13
EQ-5D TTO 2-years	0.90 ± 0.13
EQ-5D TTO 3-years	0.91 ± 0.13
EQ-5D TTO 4-years	0.9 ± 0.13
EQ-5D TTO 5-years	0.89 ± 0.15
EQ-5D TTO 7-years	0.9 ± 0.13
EQ-5D TTO 10-years	0.92 ± 0.17

SecondaryPercentage of Cases Which Did Not Have Any Component Revised

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

Time frame:: 10 years
Reported as:: Number · hips

Percentage of Cases Which Did Not Have Any Component Revised
hips	Restoration ADM X3 Device
Percentage of Cases Which Did Not Have Any Component Revised	342

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Operative Site Events	0/354 (0%)	15/354 (4.2%)	56/354 (15.8%)
Non Operative Site Events	13/333 (3.9%)	66/333 (19.8%)	0/333 (0%)

Most frequent serious events

Showing 10 of 19

Most frequent serious events
Event	Operative Site Events	Non Operative Site Events
Non-operative siteNeoplasms benign, malignant and unspecified (incl cysts and polyps)	—	13/333
Non-operative siteMusculoskeletal and connective tissue disorders	—	12/333
Operative siteMusculoskeletal and connective tissue disorders	11/354	—
Non-operative siteCardiac disorders	—	9/333
Non-operative siteGastrointestinal disorders	—	9/333
Non-operative siteInfections and infestations	—	7/333
Non-operative siteVascular disorders	—	7/333
Non-operative siteGeneral disorders	—	6/333
Non-operative siteBlood and lymphatic system disorders	—	4/333
Non-operative siteInjury, poisoning and procedural complications	—	4/333

Most frequent other events

Most frequent other events
Event	Operative Site Events	Non Operative Site Events
Operative siteMusculoskeletal and connective tissue disorders	56/354	—

Baseline characteristics

The analysis population includes 333 participants and 354 hips.

Age, Continuous
Age, Continuous(years)	Restoration ADM X3 Device
Mean age	60.99 (27 to 75)

Sex: Female, Male
Sex: Female, Male(Participants)	Restoration ADM X3 Device
Female	164
Male	169

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Restoration ADM X3 Device
American Indian or Alaska Native	2
Asian	1
Native Hawaiian or Other Pacific Islander	1
Black or African American	13
White	315
More than one race	1
Unknown or Not Reported	0

Study locations

12 sites

OrthoArizona
Gilbert, Arizona 85234, United States
Arizona Institute for Bone and Joint Disorders
Phoenix, Arizona 85016, United States
Tucson Orthopaedic Institute
Tucson, Arizona 85712, United States
Rush University Medical Center
Chicago, Illinois 60612, United States
Covenant Medical Center
Saginaw, Michigan 48602, United States
St. Cloud Orthopedic Associates
Sartell, Minnesota 56377, United States
Missouri Orthopaedic Institute
Columbia, Missouri 65212, United States
Syracuse Orthopedic Specialists
Fayetteville, New York 13066, United States
Hospital for Special Surgery
New York, New York 10021, United States
The Ottawa Hospital
Ottawa, Ontario K1H8L6, Canada
St. Michael's Hospital
Toronto, Ontario M5B 1W8, Canada
Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8
Magdeburg, Sachsen-Anhalt 39120, Germany

References and documents

Study documents

Protocol, analysis plan and consent form · Apr 15, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01420237
Lead sponsor: Stryker Orthopaedics
Responsible party: Sponsor
First posted: Aug 19, 2011
Start date: Jun 2011
Primary completion: Nov 9, 2023
Completion: Nov 9, 2023
Results posted: Jan 22, 2025
Last update: Jan 22, 2025

Study contacts

Anthony Hedley, M.D.

principal investigator · Arizona Institute for Bone & Joint Disorders

Kipling Sharpe, M.D.

principal investigator · OrthoArizona

Craig J. Della Valle, M.D.

principal investigator · Rush University Medical Center

Geoffrey Westrich, M.D.

principal investigator · Hospital for Special Surgery, New York

Joseph Nessler, M.D.

principal investigator · St. Cloud Orthopedic Associates

Brian C de Beaubien, M.D.

principal investigator · Covenant Medical Center

Christoph Lohmann, MD

principal investigator · Universitatsklinikum Madgeburg A.o.R.

Paul Kim, MD

principal investigator · The Ottawa Hospital

Amit Atrey, MD

principal investigator · Unity Health Toronto

Brett Greenky, MD

principal investigator · Syracuse Orthopedic Specialists

Ajay Aggarwal, MD

principal investigator · Missouri Orthopaedic Institute

Edward Petrow, DO

principal investigator · Tucson Orthopaedic Institute

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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