ArthropathyRASNCT05591859
Restoration Anatomic Acetabular Shell Revision Study
A study testing Restoration Anatomic Acetabular Shell in people with Arthropathy and Hip Arthropathy, run by Stryker Orthopaedics at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthropathy, Hip Arthropathy, Hip Osteoarthritis
- What is being tested?
- Restoration Anatomic Acetabular Shell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2024to 1 Mar 2036
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Regents of the University of Colorado
Denver, Colorado, 80045
About this study
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
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.
- Conditions
- Arthropathy, Hip Arthropathy, Hip Osteoarthritis
- Being tested
- Restoration Anatomic Acetabular Shell
- Medical subject headings
- Joint Diseases, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration Anatomic Acetabular ShellDevice
Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Restoration Anatomic Acetabular Shell | Other | Not described Receives: Device: Restoration Anatomic Acetabular Shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Success rate is defined as no incidence of revision for aseptic loosening
Measured: 10 years
Secondary outcomes (1)
Adverse Events
All protocol defined adverse events as well as all-cause revision and/or removal of RAS
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start2 Mar 2024
- Primary completion1 Mar 2036 (estimated)
- Study completion1 Mar 2036 (estimated)
Why it stopped: Due to due to inability to recruit sufficient eligible participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591859
- Sponsor's protocol ID
- 105
- Acronym
- RAS
- Status last verified
- Oct 2025
- First submitted
- 19 Oct 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05591859
- Acronym / sponsor ID
- RAS / 105
- Conditions
- Arthropathy, Hip Arthropathy, Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to due to inability to recruit sufficient eligible participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 1 Mar 2036 (estimated)
- Study completion
- 1 Mar 2036 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restoration Anatomic Acetabular Shell | Other | Device: Restoration Anatomic Acetabular Shell |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restoration Anatomic Acetabular ShellMulti-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively. | Device | Restoration Anatomic Acetabular Shell |
Primary outcome
Success rate
Time frame: 10 years
Success rate is defined as no incidence of revision for aseptic loosening
1 secondary outcome
Adverse Events
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restoration Anatomic Acetabular Shell in people with Arthropathy and Hip Arthropathy, run by Stryker Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.