Acetabular Shell Revision for Hip Arthritis

(RAS Trial)

Overseen By Marissa Puccio

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Orthopaedics

Must not be taking: Steroids

Disqualifiers: High BMI, Infection, Neuromuscular disorder, Bone deterioration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hip component called the Restoration Anatomic Acetabular Shell for individuals needing revision surgery after a failed total hip replacement. The goal is to evaluate how long this new shell lasts and performs in daily life. It suits those who have experienced hip replacement issues and are prepared for another surgery. Participants should not have severe bone problems or infections and must be able to attend post-surgery check-ups. As an unphased trial, it provides a unique opportunity for patients to contribute to innovative research and potentially benefit from cutting-edge treatment options.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving steroids in excess of normal physiological requirements, you may be excluded from the trial.

What prior data suggests that the Restoration Anatomic Acetabular Shell is safe for hip arthritis revision?

Research shows that the Restoration Anatomic Acetabular Shell is a sterile, single-use device designed to attach to the hip socket without glue. This device is intended for individuals needing to replace a failed component of a previous hip replacement.

The Restoration Anatomic Shell builds on a system with many years of successful results, indicating its safety. However, specific information about side effects in humans is not widely available.

Labeling the trial as "Not Applicable" for the phase indicates that it does not primarily focus on testing new safety information. Nevertheless, the device's design and past success provide some reassurance about its safety. Always consult your healthcare provider for advice tailored to your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Restoration Anatomic Acetabular Shell is unique because it aims to provide a more anatomically accurate fit for patients undergoing hip revision surgery for arthritis. Unlike traditional acetabular shells, which can sometimes lead to issues with fit and stability over time, this new shell is designed to mimic the natural anatomy of the hip more closely. Researchers are excited about this treatment because it has the potential to improve joint stability and longevity, reducing the need for future revisions and enhancing overall patient outcomes.

What evidence suggests that the Restoration Anatomic Acetabular Shell is effective for hip arthritis?

Research has shown that the Restoration Anatomic Acetabular Shell, which trial participants will receive, addresses issues from a failed hip replacement. This shell is designed to fit better and last longer than older versions. Studies have found that similar shells, such as the Trident II, successfully maintain hip joint stability and function. Patients using these shells often experience less pain and improved movement after surgery. This suggests that the Restoration Anatomic Acetabular Shell could be effective for those needing hip revision surgery. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals needing a revision of a failed hip replacement component, specifically with the Restoration Anatomic Acetabular Shell. Participants must be adults who can follow post-op check-ups and have signed an informed consent form. Those with extreme obesity (BMI > 45), infections around the hip, immune suppression, mental or neuromuscular issues affecting recovery, poor bone quality, or sensitivity to device materials cannot join.

Inclusion Criteria

I am a man or a woman not currently pregnant.

I am a candidate for hip socket revision surgery.

Subject has signed an IRB-approved, study specific Informed Consent Form (ICF)

Exclusion Criteria

I have a condition like Lupus or Paget's Disease affecting my bones.

Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care

I am on long-term steroids or have a weakened immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Restoration Anatomic Acetabular Shell as part of the revision surgery for failed total hip arthroplasty

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of adverse events and success rate

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Restoration Anatomic Acetabular Shell

Trial Overview The study is testing the long-term effectiveness ('survivorship') of the RAS acetabular shell in patients whose previous total hip arthroplasty has failed. It's a non-randomized study tracking patients both retrospectively and prospectively after they receive this specific implant.

How Is the Trial Designed?

Group I: Restoration Anatomic Acetabular Shell Experimental Treatment 1 Intervention

Restoration Anatomic Acetabular Shell is already approved in United States, European Union for the following indications:

Approved in United States as Restoration Anatomic Shell for:

• Revision of previously failed total hip arthroplasty (THA)
• Primary and revision procedures for degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis

Approved in European Union as Trident II Acetabular Shell for:

• Revision of previously failed total hip arthroplasty (THA)
• Primary and revision procedures for degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis

Who Is Running the Clinical Trial?

Stryker Orthopaedics

Lead Sponsor

Trials

79

Recruited

20,500+

Kevin A. Lobo

Stryker Orthopaedics

Chief Executive Officer since 2012

Bachelor's degree in Commerce from McGill University, MBA from University of Toronto

Dr. Jorge Enrique Diaz

Stryker Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan Medical School

Published Research Related to This Trial

Acetabular revisions using reinforcement rings and cages show good survival rates and functional outcomes, with a mean follow-up period of 8.8 years across 1327 procedures analyzed.

In cases of severe acetabular defects, the revisions still maintained a satisfactory mean Harris Hip Score of 76.3, indicating effective restoration of hip function despite challenges like aseptic and septic loosening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of cages in revision arthroplasty of the acetabulum: a systematic review. Aprato, A., Olivero, M., Branca Vergano, L., et al.[2020]

The case report demonstrates that replacing a metal-ceramic crown with a CEREC 3-D crown can significantly improve aesthetic outcomes for patients, as seen in a 42-year-old patient who was dissatisfied with their previous crown.

The success of the CEREC crown replacement relies heavily on both the precision of the dentist's preparation and the quality of the laboratory work, leading to high satisfaction for both the patient and clinician.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of the CEREC system in dental practices. Esthetic reconstruction of the anterior teeth--a case report]. Di Rocco, D.[2016]

In a review of 68 patients who underwent total hip arthroplasties using the Trident acetabular system, 8% of the metal-backed ceramic liners were found to be incompletely seated, with a higher risk of 10% in primary surgeries compared to 0% in revision surgeries.

The study suggests that shell deformation may contribute to the malseating issue, and to mitigate this risk, the authors have adjusted their surgical technique by underreaming by 0.8 mm instead of 1.8 mm, especially in cases of sclerotic bone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seating of ceramic liners in the uncemented trident acetabular shell: is there really a problem? Howcroft, DW., Qureshi, A., Graham, NM.[2021]

The use of a digital workflow combined with CAD/CAM technology in creating natural restorations allows for more predictable and aesthetically pleasing results compared to traditional methods.

In a case involving a 38-year-old patient with esthetic concerns, the interdisciplinary approach included periodontal surgery and CAD/CAM ceramic veneers, successfully restoring the natural appearance of the teeth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAD-CAM natural restorations-Reproducing nature using a digital workflow. Segundo, ÂRTC., Saraiva, S., de Castro, C., et al.[2023]

A new procedure using a custom-made template and plastic foil allows for the accurate reproduction of internal contours of existing crowns, facilitating the rebuilding of composite core foundations for teeth that have undergone endodontic treatment.

This method addresses challenges faced when retrofitting existing crowns after core fractures or recurrent caries, improving the efficiency and effectiveness of dental restorations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rebuilding core foundations for existing crowns using a custom-made template. Berksun, S.[2005]

The case study highlights the importance of interdisciplinary treatment planning and precise execution in the prosthetic rehabilitation of malpositioned anterior dental implants to achieve optimal esthetic results.

After using custom gold abutments and correcting a ridge defect, the study documented a stable and aesthetically pleasing outcome for maxillary central incisor implants over a 7-year period, demonstrating the long-term success of the approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Implant Abutment Design on Long-Term Soft Tissue Stability: A Clinical Case Report. Otero, N., Scarton, J., Pizzolante, LL., et al.[2019]

In a study of 41 patients with massive acetabular bone loss, the use of an antiprotrusio cage combined with porous metal augments showed an 87.4% survival rate free from aseptic cage failure at 10 years, indicating good long-term efficacy of this reconstruction technique.

Patients experienced a significant reduction in their need for ambulatory aids after surgery, suggesting improved functional outcomes following the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip Arthroplasty With the Use of a Reconstruction Cage and Porous Metal Augment to Treat Massive Acetabular Bone Loss: A Midterm Follow-Up. Garceau, SP., Warschawski, Y., Joly, D., et al.[2022]

The novel double-cup construct using a Trabecular Metal Revision Shell for treating Paprosky type IIIA and IIIB acetabular defects showed no cases of acetabular loosening in a study of 20 patients over a mean follow-up of 2.4 years.

While the technique demonstrated significant improvements in hip function, with average Harris Hip Scores rising from 28.2 to 68.7, a 25% dislocation rate was noted, primarily occurring within the first year post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Double-Cup Construct: A Novel Treatment Strategy for the Management of Paprosky IIIA and IIIB Acetabular Defects. Webb, JE., McGill, RJ., Palumbo, BT., et al.[2018]

A customized cage was successfully used in 23 hips of 22 patients with severe acetabular bone loss during revision total hip arthroplasty, leading to significant improvement in hip function as measured by the Harris hip score, which increased from an average of 39.6 to 80.9 after surgery.

The method showed a good safety profile with no deep infections or severe complications, although two patients experienced dislocations that were managed effectively, indicating that while the technique is promising, further long-term studies are needed to assess its durability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of customized cages in revision total hip arthroplasty for Paprosky type III acetabular bone defects. Mao, Y., Xu, C., Xu, J., et al.[2018]

In a study of 187 acetabular revisions where the old shell was retained, 25 cases required rerevision, highlighting the potential risks associated with this approach.

The rerevision rates varied significantly by shell design, with old spiked shells showing a 17% rerevision rate, suggesting that the design and condition of the existing shell should be carefully evaluated before deciding to retain it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship of polyethylene liner exchanges performed for the treatment of wear and osteolysis among porous-coated cups. Hamilton, WG., Hopper, RH., Engh, CA., et al.[2022]

The study highlights the critical role of careful planning in reconstructive procedures for the front region of the jaw, especially in patients with class III relationships, which can complicate the process.

Five patients were treated using various techniques, including bone transplants and implants, emphasizing the need for both functional and aesthetic outcomes in successful reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation of the anterior portions of the maxilla and mandible by means of implants and bone grafts]. Neyt, L., Deryckere, F., Abeloos, J., et al.[2011]

In a review of 117 hips from 113 patients who received the Trident acetabulum in total hip replacements, 16.4% showed incomplete seating of the metal-backed ceramic liner, indicating a potential issue with the implant's design or surgical technique.

The study suggests that the Trident shell may deform during implantation, which could hinder proper seating of the liner, highlighting the need for surgeons to be aware of this complication when using this prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incomplete seating of the liner with the Trident acetabular system: a cause for concern? Langdown, AJ., Pickard, RJ., Hobbs, CM., et al.[2016]

This case series reports two instances of screw penetration through the Stryker Trident II acetabular shell, highlighting a potential design flaw in the implant system during total hip arthroplasty procedures.

Both cases were managed conservatively with weight-bearing as tolerated and radiographic monitoring, suggesting that while the failures occurred, they did not require more invasive interventions, but they do emphasize the need for careful intraoperative assessment of screw placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of Screw/Shell Interface in the Trident II Acetabular System in Total Hip Arthroplasty. Ulrich, PA., Zondervan, RL., Cochran, JM.[2022]

The new acetabular shell is designed to maintain the native hip center-of-rotation (COR) while providing effective fixation during revision total hip arthroplasty (THA), particularly in cases with significant acetabular bone loss.

This case series highlights the shell's potential to successfully lower the hip COR in challenging revision THA scenarios, suggesting it may improve surgical outcomes for patients with severe bone loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difficult Revision Total Hip Arthroplasty Cases Treated with an Offset Head Center Acetabular Shell. Wassef, A., Sodhi, N., Khlopas, A., et al.[2019]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/86/NCT04317586/Prot_SAP_000.pdf

Trident II Acetabular Shell Revision Study This study will be a prospective, non-randomized evaluation of the. Trident II Acetabular Shell for revision of the acetabular component of a previously failed ...

2. withpower.com withpower.com/trial/phase-hip-arthropathy-10-2022-0cecd

Acetabular Shell Revision for Hip Arthritis (RAS Trial) This trial is for individuals needing a revision of a failed hip replacement component, specifically with the Restoration Anatomic Acetabular Shell.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04317586

NCT04317586 | Trident II Revision Outcomes Study The purpose of this study is to review the performance and success rate of an FDA cleared cementless hip replacement part called the Trident II Tritanium ...

4. stryker.com stryker.com/content/dam/stryker/education-and-training/joint-replacement/fellows-summit/2023-oct/files/hip/Restoration%20Modular%20Revision%20Hip%20System%20slide%20deck.pdf

Restoration Modular Revision Hip System slide deck Restoration Modular instruments were developed for simplicity and ease of use. Simple, straight-forward instruments designed to allow for OR efficiency. Simple.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05591859/restoration-anatomic-acetabular-shell-revision-study

Restoration Anatomic Acetabular Shell Revision Study The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive

6. stryker.com stryker.com/us/en/joint-replacement/products/trident-ii.html

Trident II Acetabular System Trident II is created for case-to-case confidence that comes from building on a system backed by years of successful clinical data and reliable features such as ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/K151264.pdf

Stryker Orthopaedics Ms. Allison Ling Regulatory Affairs ... The Restoration Anatomic Shell is a sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either ...