Clinical trial NCT01420237: Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study
Official title: Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study With Long Term Data Collection for the Accolade® II Hip Stem
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: Noninflammatory joint disease of the hip.
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2011-08-19
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.

Eligibility criteria: 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.

Primary outcomes:
measure: Success Rate
timeFrame: 10 years postoperative
Secondary outcomes:
measure: Harris Hip Score (HHS) Score Improvement From Preoperative Score
timeFrame: pre-op, 6 week, 1,2,3,4,5 years. 7 and 10 years were optional.
measure: All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System
timeFrame: 10 years
measure: Patient Satisfaction and Pain: Follow-up Questionnaire
timeFrame: 6-10 years
measure: Radiographic Stability Rates
timeFrame: 6 week,1, 2, 3, 4, 5 years
measure: Complication Rates for Psoas Impingement and Associated Groin Pain
timeFrame: 10 years
measure: Short Form-12 (SF-12) Improvement From Preoperative Score
timeFrame: preop, 6 week, 1,2,3,4,5 years
measure: Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score
timeFrame: preop, 6 week, 1,2,3,4,5 years
measure: EQ-5D Index Score Improvement From Preoperative Score
timeFrame: preop, 6 week, 1,2,3,4,5 years
measure: Percentage of Cases Which Did Not Have Any Component Revised
timeFrame: 10 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: OrthoArizona
state: Arizona
city: Phoenix
country: United States
facility: Arizona Institute for Bone and Joint Disorders
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
city: Sartell
country: United States
facility: St. Cloud Orthopedic Associates
state: Minnesota
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
city: Fayetteville
country: United States
facility: Syracuse Orthopedic Specialists
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Magdeburg
country: Germany
facility: Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8
state: Sachsen-Anhalt
Study officials:
affiliation: Arizona Institute for Bone & Joint Disorders
name: Anthony Hedley, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: OrthoArizona
name: Kipling Sharpe, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Craig J. Della Valle, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Geoffrey Westrich, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Cloud Orthopedic Associates
name: Joseph Nessler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Covenant Medical Center
name: Brian C de Beaubien, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitatsklinikum Madgeburg A.o.R.
name: Christoph Lohmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital
name: Paul Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Amit Atrey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Syracuse Orthopedic Specialists
name: Brett Greenky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Missouri Orthopaedic Institute
name: Ajay Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tucson Orthopaedic Institute
name: Edward Petrow, DO
role: PRINCIPAL_INVESTIGATOR
References: