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

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study With Long Term Data Collection for the Accolade® II Hip Stem

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01420237
• Other study ID #: 70
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2011
• Est. completion date: June 2026

Study information

• Verified date: November 2023
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 352
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Germany	Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8	Magdeburg	Sachsen-Anhalt
United States	Rush University Medical Center	Chicago	Illinois
United States	Missouri Orthopaedic Institute	Columbia	Missouri
United States	Syracuse Orthopedic Specialists	Fayetteville	New York
United States	OrthoArizona	Gilbert	Arizona
United States	Hospital for Special Surgery	New York	New York
United States	Arizona Institute for Bone and Joint Disorders	Phoenix	Arizona
United States	Covenant Medical Center	Saginaw	Michigan
United States	St. Cloud Orthopedic Associates	Sartell	Minnesota
United States	Tucson Orthopaedic Institute	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate	Defined as absence of postoperative femoral head dislocation.	10 years postoperative
Secondary	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	pre-op, 6 week, 1,2,3,4,5 years
Secondary	All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System		10 years
Secondary	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	6-10 years
Secondary	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.	6 week,1,2,3,4,5
Secondary	Complication rates for Psoas Impingement and Associated Groin Pain		10 years
Secondary	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.	preop, 6 week, 1,2,3,4,5 years
Secondary	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.	preop, 6 week, 1,2,3,4,5 years
Secondary	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, where an overall score of 1 represents full health.	preop, 6 week, 1,2,3,4,5 years
Secondary	Percentage of cases which did not have any component revised		10 years