- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01420237
Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study
Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study With Long Term Data Collection for the Accolade® II Hip Stem
Study Overview
Status
Conditions
Intervention / Treatment
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Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1H8L6
- The Ottawa Hospital
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Germany, 39120
- Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8
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Arizona
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Gilbert, Arizona, United States, 85234
- OrthoArizona
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Phoenix, Arizona, United States, 85016
- Arizona Institute for Bone and Joint Disorders
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Tucson, Arizona, United States, 85712
- Tucson Orthopaedic Institute
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Michigan
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Saginaw, Michigan, United States, 48602
- Covenant Medical Center
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Minnesota
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Sartell, Minnesota, United States, 56377
- St. Cloud Orthopedic Associates
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Missouri
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Columbia, Missouri, United States, 65212
- Missouri Orthopaedic Institute
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New York
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Fayetteville, New York, United States, 13066
- Syracuse Orthopedic Specialists
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New York, New York, United States, 10021
- Hospital for Special Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Restoration ADM X3 Device
Restoration ADM X3 Device in total hip replacement.
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Restoration ADM X3 Device in total hip replacement.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success Rate
Time Frame: 10 years postoperative
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Defined as absence of postoperative femoral head dislocation.
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10 years postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Harris Hip Score (HHS) score improvement from preoperative score
Time Frame: pre-op, 6 week, 1,2,3,4,5 years
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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
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pre-op, 6 week, 1,2,3,4,5 years
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All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System
Time Frame: 10 years
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10 years
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Patient Satisfaction and Pain: Follow-up Questionnaire
Time Frame: 6-10 years
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This questionnaire will be used to obtain the following information:
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6-10 years
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Radiographic Stability Rates
Time Frame: 6 week,1,2,3,4,5
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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.
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6 week,1,2,3,4,5
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Complication rates for Psoas Impingement and Associated Groin Pain
Time Frame: 10 years
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10 years
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Short Form-12 (SF-12) improvement from preoperative score
Time Frame: preop, 6 week, 1,2,3,4,5 years
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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.
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preop, 6 week, 1,2,3,4,5 years
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Lower Extremity Activity Scale (LEAS) improvement from preoperative score
Time Frame: preop, 6 week, 1,2,3,4,5 years
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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.
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preop, 6 week, 1,2,3,4,5 years
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EQ-5D Index Score improvement from preoperative score
Time Frame: preop, 6 week, 1,2,3,4,5 years
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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, where an overall score of 1 represents full health.
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preop, 6 week, 1,2,3,4,5 years
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Percentage of cases which did not have any component revised
Time Frame: 10 years
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10 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brett Greenky, MD, Syracuse Orthopedic Specialists
- Principal Investigator: Edward Petrow, DO, Tucson Orthopaedic Institute
- Principal Investigator: Anthony Hedley, M.D., Arizona Institute for Bone & Joint Disorders
- Principal Investigator: Kipling Sharpe, M.D., OrthoArizona
- Principal Investigator: Craig J. Della Valle, M.D., Rush University Medical Center
- Principal Investigator: Geoffrey Westrich, M.D., Hospital for Special Surgery, New York
- Principal Investigator: Joseph Nessler, M.D., St. Cloud Orthopedic Associates
- Principal Investigator: Brian C de Beaubien, M.D., Covenant Medical Center
- Principal Investigator: Christoph Lohmann, MD, Universitatsklinikum Madgeburg A.o.R.
- Principal Investigator: Paul Kim, MD, The Ottawa Hospital
- Principal Investigator: Ajay Aggarwal, MD, Missouri Orthopaedic Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 70
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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