Surgical Approaches for Total Hip Replacement

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Infection, Morbid obesity, Osteoporosis, others

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

Compensation: Varies

Number of Visits: 5

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 data supports the effectiveness of this treatment for total hip replacement?

Research shows that the direct superior approach (DSA) for total hip replacement can lead to earlier recovery and shorter hospital stays compared to the standard posterior approach. Additionally, the DSA is a minimally invasive technique that may offer similar outcomes in terms of hospital stay and blood loss when compared to other approaches. ^{1 2 3 4 5}

Is total hip replacement surgery safe for humans?

Research shows that total hip replacement, whether using the direct superior, posterior, or anterior approaches, is generally safe for humans. Studies have compared these methods and found no significant differences in early complications or safety concerns. ^{1 3 6 7 8}

How does the direct superior approach for total hip replacement differ from other treatments?

The direct superior approach for total hip replacement is unique because it is a minimally invasive technique that preserves more soft tissue, potentially leading to quicker recovery and less pain compared to the standard posterior approach. It also allows for accurate implant positioning and has a learning curve of about 40 surgeries to achieve proficiency. ^{1 2 4 7 9}

What is the purpose of this trial?

Hip replacement surgery is an effective option for treating pain and functional impairment in chronic hip conditions. Various surgical approaches have been developed to expose the hip joint for the procedure, each with advantages and disadvantages. The posterior approach (PA) to total hip replacement is a commonly used exposure method. This approach involves a large incision and requires multiple cuts through muscle and other soft tissues to expose the hip joint. Despite excellent outcomes, the PA is known to have an increased rate of dislocation compared to other exposures. The direct superior (DS) approach has been developed to improve the PA by decreasing the amount of soft tissue injury at the time of surgery and improving postoperative stability. The DS approach involves a much shorter incision and reduces the need to damage as much soft tissues surrounding the hip joint during exposure. Specialized equipment developed for this technique allows the surgeon to place the hip replacement components. The proposed research study is designed to address a deficit in knowledge regarding outcomes on patients who have had a DS approach for total hip arthroplasty. This study will provide much needed insight into the advantages and disadvantages of the DS approach as compared to PA for total hip arthroplasty.

Eligibility Criteria

This trial is for adults aged 18-80 with hip pain from osteoarthritis, indicating they need surgery. They must be suitable for a specific type of hip implant and able to consent to the study. It's not open to those who don't meet these criteria.

Inclusion Criteria

Ability to give informed consent

Uncemented femoral stem and acetabular cup indicated

I need surgery for my painful hip arthritis.

Exclusion Criteria

I have severe bone loss.

Patients with known or tested-positive allergy to metals

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo total hip arthroplasty using either the direct superior or posterior approach

1 day

1 visit (in-person)

Postoperative Recovery

Participants recover from surgery, with monitoring of narcotic use, length of stay, and complications

0-30 days

Follow-up

Participants are monitored for safety and effectiveness after surgery, with follow-up exams at 6 weeks, 6 months, 12 months, and 24 months

24 months

4 visits (in-person)

Treatment Details

Interventions

• Direct Superior Approach
• Posterior Approach
• Total Hip Arthroplasty

Trial Overview The study compares two surgical methods for hip replacement: the Direct Superior (DS) approach, which uses a smaller cut and less soft tissue damage, versus the traditional Posterior Approach (PA), known for higher dislocation rates but excellent outcomes.

Participant Groups

Group I: Direct Superior Approach Experimental Treatment 2 Interventions

The intervention being tested is the surgical approach.

Group II: Posterior Approach Active Control 2 Interventions

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

References

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

Earlier functional recovery and discharge from hospital for THA patients operated on via direct superior compared to standard posterior approach: a retrospective frequency-matched case-control study. [2023]

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

Early Outcome Comparison of the Posterior Approach and the Superior Approach for Primary Total Hip Arthroplasty. [2022]

3. Sweden pubmed.ncbi.nlm.nih.gov

No clinically relevant difference in patient-reported outcomes between the direct superior approach and the posterolateral or anterior approach for primary total hip arthroplasty: analysis of 37,976 primary hip arthroplasties in the Dutch Arthroplasty Registry. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Clinical, functional and radiographic outcomes of primary total hip arthroplasty between direct anterior approach and posterior approach: a systematic review and meta-analysis. [2021]

5. Australia pubmed.ncbi.nlm.nih.gov

No Learning Curve of the Direct Superior Approach in Total Hip Arthroplasty. [2020]

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

A Comparison of Risk of Dislocation and Cause-Specific Revision Between Direct Anterior and Posterior Approach Following Elective Cementless Total Hip Arthroplasty. [2023]

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

Length of Stay, Discharge Disposition, and 90-Day Complications and Revisions Following Primary Total Hip Arthroplasty: A Comparison of the Direct Anterior, Posterolateral, and Direct Superior Approaches. [2021]

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

A comparison of clinical, radiographic and surgical outcomes of total hip arthroplasty between direct anterior and posterior approaches: a systematic review and meta-analysis. [2022]

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

The direct superior approach in total hip arthroplasty. [2020]