Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Arthropathy of Hip |
Device: Restoration ADM X3 Device |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective, Post-market, Multi-center Study of the Restoration® ADM X3® Acetabular System |
- Survival Rate [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]To evaluate and determine the success rate, defined as absence of postoperative femoral head dislocation, at 10 years with the Restoration® ADM X3® Acetabular System. The number of patients with femoral head dislocations will be counted to calculate a Kaplan Meier Survival Curve for the device.
- Quality of Life Outcomes [ Time Frame: 10 years postoperative ] [ Designated as safety issue: No ]
To compare function and health related quality of life (QOL) between the Restoration® ADM X3® Acetabular System and published results for other primary hip systems. The following outcomes measures will be used for this comparison: Harris Hip Score (HHS), Short Form-12 (SF-12), Lower Extremity Activity Scale (LEAS), EQ-5D.
1-year, 2-year, 3-year, 4-year and 5-year HHS, SF-12 and LEAS will be compared to literature control with respect to improvement from preoperative scores. The EQ-5D data will be summarized and presented.
- Functional Outcome [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]To evaluate all-cause revision and removal rates in the Restoration® ADM X3® acetabular system and compare with those reported for other primary hip systems in the literature.
| Estimated Enrollment: | 350 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | August 2024 |
| Estimated Primary Completion Date: | August 2024 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Restoration ADM X3 Device
Restoration ADM X3 Device in total hip replacement.
|
Device: Restoration ADM X3 Device
Restoration ADM X3 Device in total hip replacement.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients of participating investigators undergoing Total Hip Arthroplasty and meeting the Inclusion Criteria will be invited to participate in the study.
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.
Contacts and Locations| Contact: Carinna Kison | 973-800-2744 | carinna.kison@stryker.com |
| Contact: Danielle Anthony | 201-831-5498 | danielle.anthony@stryker.com |
| United States, Arizona | |
| Mezona Orthopedics | Recruiting |
| Gilbert, Arizona, United States, 85234 | |
| Contact: Leigh Breslauer 602-667-7965 lbreslauer@cox.net | |
| Principal Investigator: Kipling Sharpe, M.D. | |
| Arizona Institute for Bone and Joint Disorders | Terminated |
| Phoenix, Arizona, United States, 85016 | |
| United States, Illinois | |
| Rush University Medical Center | Active, not recruiting |
| Chicago, Illinois, United States, 60612 | |
| United States, Michigan | |
| Covenant Medical Center | Recruiting |
| Saginaw, Michigan, United States, 48602 | |
| Contact: Kim Garza, RN, BSN 989-583-6232 kgarza@chs-mi.com | |
| Principal Investigator: Brian C de Beaubien, MD | |
| United States, Minnesota | |
| St. Cloud Orthopedic Associates | Recruiting |
| Sartell, Minnesota, United States, 56377 | |
| Contact: Jerry Nelson, OPA-C 320-259-8044 jnelson@stcloudorthopedics.com | |
| Contact: Erik Hanson, PA 320-259-8044 ehanson@stcloudorthopedics.com | |
| Principal Investigator: Joseph Nessler, MD | |
| United States, New York | |
| Hospital for Special Surgery | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Natalie Parkes 212-774-7513 parkesn@hss.edu | |
| Principal Investigator: Geoffrey Westrich, M.D. | |
| Principal Investigator: | Anthony Hedley, M.D. | Arizona Institute for Bone & Joint Disorders |
| Principal Investigator: | Kipling Sharpe, M.D. | Mezona Orthopedics |
| 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: | Douglas Padgett, 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 |
More Information
No publications provided
| Responsible Party: | Stryker Orthopaedics |
| ClinicalTrials.gov Identifier: | NCT01420237 History of Changes |
| Other Study ID Numbers: | 70 |
| Study First Received: | March 18, 2011 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Stryker Orthopaedics:
|
Noninflammatory joint disease of the hip. |
Additional relevant MeSH terms:
|
Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013