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

NCT01420237 | Terminated Results

• 1 other identifier: 70
• Study Type: interventional
• Target: 367
• Locations: 3 countries
• Sites: 12

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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

Noninflammatory joint disease of the hip.

Outcome Measures

Primary Outcomes (1)

• Success Rate

  Defined as absence of postoperative femoral head dislocation.

  10 years postoperative

Secondary Outcomes (9)

• Harris Hip Score (HHS) Score Improvement From Preoperative Score

  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

  10 years

• Patient Satisfaction and Pain: Follow-up Questionnaire

  6-10 years

• Radiographic Stability Rates

  6 week,1, 2, 3, 4, 5 years

• Complication Rates for Psoas Impingement and Associated Groin Pain

  10 years

Study Arms (1)

Restoration ADM X3 Device

OTHER

Restoration ADM X3 Device in total hip replacement.

Device: Restoration ADM X3 Device

Interventions

Restoration ADM X3 Device DEVICE

Restoration ADM X3 Device in total hip replacement.

Restoration ADM X3 Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (12)

OrthoArizona

Gilbert, Arizona, 85234, United States

Location

Arizona Institute for Bone and Joint Disorders

Phoenix, Arizona, 85016, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Covenant Medical Center

Saginaw, Michigan, 48602, United States

Location

St. Cloud Orthopedic Associates

Sartell, Minnesota, 56377, United States

Location

Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

Syracuse Orthopedic Specialists

Fayetteville, New York, 13066, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Limitations and Caveats

Due to circumstances starting with the COVID-19 pandemic and challenges recalling study subjects for long term postoperative visits, the follow-up compliance decreased significantly. Therefore, there would be inadequate subjects to analyze at the 10 year endpoint. For this reason, a business decision was made to close the study early.

Results Point of Contact

• Title: Kevin Barga, Senior Manager, Clinical Affairs
• Organization: Stryker Orthopaedics

Kevin.Barga@stryker.com

201-831-5000

Study Officials

• 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

• Amit Atrey, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Brett Greenky, MD

  Syracuse Orthopedic Specialists

  PRINCIPAL INVESTIGATOR

• Ajay Aggarwal, MD

  Missouri Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• Edward Petrow, DO

  Tucson Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: August 19, 2011
• Study Start: June 1, 2011
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Locations

DE (1); US (9); CA (2)