Hip Revision Surgery Technique for Hip Osteoarthritis

Overseen By Sarah Tran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Orthopaedic Innovation Centre

Disqualifiers: Infection, Metal allergy, Obesity, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technique for hip revision surgery using the REDAPT Revision Hip System to treat hip osteoarthritis. Researchers aim to evaluate how well the new hip components remain stable over time and how much they enhance a patient's mobility and overall health. They seek patients needing hip revision surgery, meaning their current hip implant requires repair or replacement, and who do not have severe obesity or infections. This trial may suit those experiencing issues like pain or limited movement from a hip implant. As an unphased study, this trial offers a unique opportunity to contribute to innovative surgical advancements that could improve future patient care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this hip revision surgery technique is safe for patients with hip osteoarthritis?

Research has shown that the REDAPT Revision Hip System is generally a safe treatment option. Studies have found that this hip system delivers good short-term results. Specifically, a modern version of this system demonstrated positive outcomes in patients who underwent complex hip surgeries.

However, some early studies reported a high rate of subsidence, meaning the hip implant might shift slightly from its original position. This potential concern is not uncommon in hip revision surgeries and can be monitored over time. Importantly, other studies examining safety and effectiveness up to 10 years post-surgery have shown no major safety issues.

Overall, despite some early concerns, the system appears well-tolerated with careful monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the REDAPT Revision Hip System because it offers a versatile approach for hip osteoarthritis that allows for specific revisions to the hip joint. Unlike current treatments, which often involve more invasive full replacement surgeries, this system can target only the necessary parts, like the cup and stem, or just one of them. This targeted approach could lead to less trauma for patients and potentially faster recovery times, making it a promising alternative to existing procedures.

What evidence suggests that this hip revision surgery technique is effective for hip osteoarthritis?

Research has shown that the REDAPT Revision Hip System, which participants in this trial will receive, holds promise for hip revision surgeries. The system includes 3D-printed titanium parts that promote bone integration, crucial for long-term stability. One study found these parts performed well and lasted in complex hip surgeries. Additionally, similar titanium stems used in REDAPT have demonstrated excellent results in hip revision surgeries. Although some early results indicated the implant moved more than expected, overall, the system has been associated with positive short-term outcomes. ^{1 2 4 5 6}

Who Is on the Research Team?

Thomas Turgeon, MD

Principal Investigator

Concordia Joint Replacement Group

Are You a Good Fit for This Trial?

This trial is for adults needing hip revision surgery due to osteoarthritis, who can follow the study's procedures and self-evaluations. They must be able to use the standard implant without special requirements. Excluded are those with severe obesity (BMI>40), unresolved infections, certain joint diseases, known metal allergies to device components, or participation in another clinical study within 30 days.

Inclusion Criteria

Patients willing and able to comply with follow-up requirements and self-evaluations

Ability to give informed consent

I need a hip revision surgery for either the femoral stem, acetabular cup, or both.

Exclusion Criteria

You need a type of joint replacement that is not metal on polyethylene.

I need surgery to treat an infection.

I have a condition that causes joint inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo revision hip arthroplasty and initial recovery

2 weeks

1 visit (in-person)

Post-operative Assessment

Participants are assessed for changes in patient satisfaction, Oxford-12 Hip Score, EQ-5D-5L, and Pain VAS at 6 months, 1 year, and 2 years

2 years

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including RSA migrations and radiolucency evaluations

5 years

What Are the Treatments Tested in This Trial?

Interventions

• REDAPT Revision Hip System

Trial Overview The REDAPT Revision Hip System is being tested for its stability and fixation in patients undergoing hip revision surgery. The focus is on measuring stem subsidence and cup migration over a period of up to five years using model-based RSA imaging techniques.

How Is the Trial Designed?

Group I: Hip revision Experimental Treatment 3 Interventions

Revision to cup and stem, cup only or stem only.

Who Is Running the Clinical Trial?

Orthopaedic Innovation Centre

Lead Sponsor

Trials

7

Recruited

670+

Published Research Related to This Trial

In a study of 2,146 patients undergoing elective knee, hip, and spine surgeries for degenerative conditions, the overall adverse event rate was 27%, with spinal surgeries having the highest rate of severe adverse events.

Key risk factors for adverse events included increasing age, male sex, longer operative duration, longer hospital stays, and undergoing revision surgery, highlighting the need for careful patient assessment and procedural efficiency improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. Millstone, DB., Perruccio, AV., Badley, EM., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04541693

NCT04541693 | REDAPT Revision Hip System With RSA The principal objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9576483/

Minimum 2-Year Outcomes of a Novel 3D-printed Fully ... This novel 3-D printed fully porous titanium shell in rTHA demonstrated good survivorship and osseointegration when used in complex acetabular reconstruction ...

3. athenaeumpub.com athenaeumpub.com/wp-content/uploads/Outcomes-of-a-Novel-Modular-Porous-Acetabular-Shell-in-Revision-Total-Hip-Arthroplasty.pdf

Outcomes-of-a-Novel-Modular-Porous-Acetabular-Shell-in- ... This study reports one- and two-year outcomes of a novel modular porous acetabular shell used in the treatment of acetabular bone loss in the ...

4. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00251-1/fulltext

Minimum 2-Year Outcomes of a Modern Monoblock ... Modular titanium fluted tapered (TFT) stems have demonstrated excellent clinical success for femoral revision total hip arthroplasty (THA) surgery.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32009430/

Short-term outcomes with the REDAPT monolithic, tapered, ... Although good clinical outcomes have been reported for monolithic tapered, fluted, titanium stems (TFTS), early results showed high rates of subsidence.

6. ctv.veeva.com ctv.veeva.com/study/redapt-revision-system-study-to-assess-5-year-revision-rate-up-to-10-year-revision-rate-and-safety

REDAPT Revision System Study to Assess 5 Year Revision ... Additional data will be collected as outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery. Full description.