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Restoration Anatomic Acetabular Shell Revision Study (RAS)

Primary Purpose

Arthropathy, Hip Arthropathy, Hip Osteoarthritis

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Restoration Anatomic Acetabular Shell

About this trial

This is an interventional treatment trial for Arthropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell.
Subject has signed an IRB-approved, study specific Informed Consent Form (ICF).
Subject is skeletally mature.
Subject is a male or non-pregnant female.
Subject is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

Subject has a non-Stryker retained stem at the time of study device implantation.
Subject has a Body Mass Index (BMI) > 45.
Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. > 30 days).
Subject has a known sensitivity to device materials.
Subject is a prisoner.

Sites / Locations

Regents of the University of Colorado

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Restoration Anatomic Acetabular Shell

Arm Description

Outcomes

Primary Outcome Measures

Success rate

Success rate is defined as no incidence of revision for aseptic loosening

Secondary Outcome Measures

Adverse Events

All protocol defined adverse events as well as all-cause revision and/or removal of RAS

Full Information

NCT ID

NCT05591859

First Posted

October 19, 2022

Last Updated

February 9, 2023

Sponsor

Stryker Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT05591859

Brief Title

Restoration Anatomic Acetabular Shell Revision Study

Acronym

RAS

Official Title

Restoration Anatomic Acetabular Shell Revision Study - A Post-market, Multi-center Evaluation of the Clinical Outcomes of the Restoration Anatomic Acetabular Shell in a Revision Indication

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 28, 2023 (Anticipated)

Primary Completion Date

May 31, 2033 (Anticipated)

Study Completion Date

May 31, 2038 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stryker Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive series of subjects who meet the eligibility criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthropathy, Hip Arthropathy, Hip Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Restoration Anatomic Acetabular Shell

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Restoration Anatomic Acetabular Shell

Intervention Description

Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.

Primary Outcome Measure Information:

Title

Success rate

Description

Success rate is defined as no incidence of revision for aseptic loosening

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Adverse Events

Description

All protocol defined adverse events as well as all-cause revision and/or removal of RAS

Time Frame

10 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell. Subject has signed an IRB-approved, study specific Informed Consent Form (ICF). Subject is skeletally mature. Subject is a male or non-pregnant female. Subject is willing and able to comply with postoperative scheduled clinical evaluations. Exclusion Criteria: Subject has a non-Stryker retained stem at the time of study device implantation. Subject has a Body Mass Index (BMI) > 45. Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis. Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. > 30 days). Subject has a known sensitivity to device materials. Subject is a prisoner.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stryker JR Clinical Research

Phone

201-831-5000

StrykerJRClinical@stryker.com

Facility Information:

Facility Name

Regents of the University of Colorado

City

Denver

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frank Somoza

frank.somoza@cuanschutz.edu

First Name & Middle Initial & Last Name & Degree

Craig Hogan, MD

12. IPD Sharing Statement

Learn more about this trial

Restoration Anatomic Acetabular Shell Revision Study

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