Arthroplasty, Replacement, HipNCT01420237
Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study
A study testing Restoration ADM X3 Device in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 12 sites in 3 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Restoration ADM X3 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jun 2011to 9 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
Rush University Medical Center
Chicago, Illinois, 60612
Missouri Orthopaedic Institute
Columbia, Missouri, 65212
Syracuse Orthopedic Specialists
Fayetteville, New York, 13066
OrthoArizona
Gilbert, Arizona, 85234
Hospital for Special Surgery
New York, New York, 10021
Arizona Institute for Bone and Joint Disorders
Phoenix, Arizona, 85016
Covenant Medical Center
Saginaw, Michigan, 48602
St. Cloud Orthopedic Associates
Sartell, Minnesota, 56377
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Canada2 sites
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Germany1 site
Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study With Long Term Data Collection for the Accolade® II Hip Stem
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
- Arthroplasty, Replacement, Hip
- Being tested
- Restoration ADM X3 Device
- Keywords
- Noninflammatory joint disease of the hip.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration ADM X3 DeviceDevice
Restoration ADM X3 Device in total hip replacement.
| Study group | Role | What they receive |
|---|---|---|
| Restoration ADM X3 Device | Other | Restoration ADM X3 Device in total hip replacement. Receives: Device: Restoration ADM X3 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Defined as absence of postoperative femoral head dislocation.
Measured: 10 years postoperative
Secondary outcomes (9)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startJun 2011
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Why it stopped: As longitudinal patient follow-up continues to lag, it has been determined that the study is no longer able to meet its objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Hedley, M.D., Principal investigator, Arizona Institute for Bone & Joint DisordersKipling Sharpe, M.D., Principal investigator, OrthoArizonaCraig J. Della Valle, M.D., Principal investigator, Rush University Medical CenterGeoffrey Westrich, M.D., Principal investigator, Hospital for Special Surgery, New YorkJoseph Nessler, M.D., Principal investigator, St. Cloud Orthopedic AssociatesBrian C de Beaubien, M.D., Principal investigator, Covenant Medical CenterChristoph Lohmann, MD, Principal investigator, Universitatsklinikum Madgeburg A.o.R.Paul Kim, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420237
- Sponsor's protocol ID
- 70
- Status last verified
- Jan 2025
- First submitted
- 18 Mar 2011
- Last updated
- 22 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study With Long Term Data Collection for the Accolade® II Hip Stem
- ClinicalTrials.gov ID
- NCT01420237
- Acronym / sponsor ID
- 70
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Noninflammatory joint disease of the hip.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As longitudinal patient follow-up continues to lag, it has been determined that the study is no longer able to meet its objectives.
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restoration ADM X3 Device | Other | Device: Restoration ADM X3 DeviceRestoration ADM X3 Device in total hip replacement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restoration ADM X3 DeviceRestoration ADM X3 Device in total hip replacement. | Device | Restoration ADM X3 Device |
Primary outcome
Success Rate
Time frame: 10 years postoperative
Defined as absence of postoperative femoral head dislocation.
9 secondary outcomes
Harris Hip Score (HHS) Score Improvement From Preoperative Score
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
Time frame: 10 years
Patient Satisfaction and Pain: Follow-up Questionnaire
Time frame: 6-10 years
Radiographic Stability Rates
Time frame: 6 week,1, 2, 3, 4, 5 years
Complication Rates for Psoas Impingement and Associated Groin Pain
Time frame: 10 years
Short Form-12 (SF-12) Improvement From Preoperative Score
Time frame: preop, 6 week, 1,2,3,4,5 years
Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score
Time frame: preop, 6 week, 1,2,3,4,5 years
EQ-5D Index Score Improvement From Preoperative Score
Time frame: preop, 6 week, 1,2,3,4,5 years
Percentage of Cases Which Did Not Have Any Component Revised
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Arthroplasty, Replacement, Hip
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness
RecruitingObservational study
Tau Pathology in the Brain After Hip or Knee Replacement Surgery
Postoperative Cognitive Dysfunction, Alzheimer Disease
Not yet recruitingObservational study
Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery
Hypotension After Spinal Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restoration ADM X3 Device in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: 10 years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.