Restoration Anatomic Acetabular Shell Revision Study | NCT05591859

Studies
Restoration Anatomic Acetabular Shell Revision Study

NCT05591859

Sponsor

Stryker Orthopaedics

Status

Withdrawn

Last Update Posted

May 18, 2026Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Arthropathy
Hip Arthropathy
Hip Osteoarthritis

Interventions

Restoration Anatomic Acetabular Shell

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to due to inability to recruit sufficient eligible participants.

Expanded Access Info

Start Date

Mar 2, 2024Actual

Primary Completion Date

Mar 1, 2036Estimated

Completion Date

Mar 1, 2036Estimated

First Submitted Date

Oct 19, 2022

First Submission Date that Met QC Criteria

Oct 19, 2022

First Posted Date

Oct 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2026

Last Update Posted Date

May 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Restoration Anatomic Acetabular Shell	Other		Device: Restoration Anatomic Acetabular Shell

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Restoration Anatomic Acetabular Shell	Device	Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate	Success rate is defined as no incidence of revision for aseptic loosening	10 years

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	All protocol defined adverse events as well as all-cause revision and/or removal of RAS	10 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007592	Joint Diseases
D015207	Osteoarthritis, Hip

ID	Term
D009140	Musculoskeletal Diseases
D010003	Osteoarthritis
D001168	Arthritis
D012216	Rheumatic Diseases