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

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Secondary objectives include; evaluate the progression of migration between 1 and 2 years and between 2 and 5 years, assess pre- to post-surgery patient improvement in function and health status, evaluate femoral and acetabular radiolucency at 2 and 5 years, and assess patterns of stem migrate on for different revision scenarios (preservation of the trochanters and extended trochanteric osteotomy).

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.

Is the REDAPT Revision Hip System safe for humans?

The REDAPT Revision Hip System, like other hip arthroplasty techniques, may have risks such as infections and other adverse events, but these are generally low and often preventable. A study found that only 8% of major preventable adverse events after hip surgeries were filed as claims, indicating that while complications can occur, they are not very common. ^{1 2 3 4 5}

How is the REDAPT Revision Hip System treatment different from other treatments for hip osteoarthritis?

The REDAPT Revision Hip System is unique because it is specifically designed for complex hip revision surgeries, potentially offering improved stability and fit in cases of advanced bone loss. This system may incorporate advanced templating techniques, like 3D planning, to enhance surgical accuracy and outcomes compared to traditional methods. ^{3 6 7 8 9}

What data supports the effectiveness of the REDAPT Revision Hip System treatment for hip osteoarthritis?

The research highlights the importance of accurate planning and new surgical techniques in revision hip surgeries, which can help prevent complications and improve outcomes. Although specific data on the REDAPT Revision Hip System is not provided, advancements in revision hip arthroplasty techniques and tools suggest potential effectiveness in treating hip osteoarthritis. ^{3 7 8 10 11}

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. China pubmed.ncbi.nlm.nih.gov

[Surgical treatment of recurrent dislocation after total hip arthroplasty: the algorithmic approach and clinical outcome]. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Migration Patterns for Revision Total Hip Arthroplasty in the United States as Reported in the American Joint Replacement Registry. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[What can be done when hip prostheses fail? : New trends in revision endoprosthetics]. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[The direct anterior approach to the hip revision]. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of the Accuracy of 2D and 3D Templating for Revision Total Hip Replacement. [2023]

6. Sweden pubmed.ncbi.nlm.nih.gov

Only 8% of major preventable adverse events after hip arthroplasty are filed as claims: a Swedish multi-center cohort study on 1,998 patients. [2021]

7. France pubmed.ncbi.nlm.nih.gov

The cement-in-cement technique is a reliable option in hip arthroplasty revision surgery: a systematic review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Safe surgical technique: iliac osteotomy via the anterior approach for revision hip arthroplasty. [2020]

10. China pubmed.ncbi.nlm.nih.gov

[Revision total hip arthroplasty for the failed hemiarthroplasty]. [2007]

11. United States pubmed.ncbi.nlm.nih.gov

Cementation of a Dual Mobility Cup Into an Existing Well-Fixed Metal Shell: A Reliable Option to Manage Wear-Related Recurrent Dislocation in Patients With High Surgical Risk. [2021]