Anterior vs Lateral Approach for Hip Fracture Repair

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Under 18

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Recent research has demonstrated that a hemiarthroplasty (replacement of half the joint) has lower rates of post-surgical complications than a total hip arthroplasty does. However, surgeons tend to vary in their approach to hemiarthroplasties. The lateral approach, which involves making an incision at the side of the patient's hip, requires surgeons to cut through the muscle to access the hip, which has been associated with greater muscle damage and slower rates of recovery. On the other hand, the direct anterior approach does not require the cutting of the patient's muscle and is therefore associated with minimal muscle damage and faster rates of recovery. This study will aim to assess the impact of the surgical approach (Direct Anterior Approach vs. Lateral approach) during hemiarthroplasty on patients' short-term mobility, quality of life, function, pain, and safety parameters.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Anterior vs Lateral Approach for Hip Fracture Repair is an effective treatment?

The available research shows that the Direct Anterior Approach (DAA) for hip fracture repair can be more effective than the Lateral Approach (LA) in several ways. Studies indicate that DAA may lead to less muscle damage, which can help patients move better and faster after surgery. It is also linked to fewer complications and a lower chance of dying within a year after the surgery. Additionally, DAA might result in better hip function and quality of life compared to LA. These findings suggest that DAA could be a better option for treating hip fractures, especially in elderly patients. ^{1 2 3 4 5}

What safety data exists for the anterior and lateral approaches in hip fracture repair?

The Direct Anterior Approach (DAA) is compared to the Lateral Approach (LA) in several studies. The DAA is noted for minimizing soft tissue damage, potentially leading to improved postoperative mobility and fewer complications. However, it may have an increased risk of intra- and postoperative complications. Studies include a prospective comparison of DAA and LA in hemiarthroplasty, a meta-analysis of clinical outcomes in total hip arthroplasty, and a review of complications associated with DAA. The DAA is also evaluated in geriatric patients with femoral neck fractures, showing clinical and radiological outcomes. ^{1 4 6 7 8}

Is the Direct Anterior Approach a promising treatment for hip fracture repair?

Yes, the Direct Anterior Approach (DAA) is promising because it minimizes soft tissue damage, which can lead to better early mobility, fewer complications, and improved quality of life after surgery. ^{1 2 4 5 9}

Eligibility Criteria

This trial is for patients needing a hemiarthroplasty due to a femoral neck fracture. Participants must be able to read, write, and sign an informed consent form.

Inclusion Criteria

I am having a partial hip replacement due to a hip fracture.

Patients capable of reading, writing and signing an informed consent form

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo hemiarthroplasty using either the lateral or direct anterior approach

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for short-term mobility, quality of life, function, pain, and safety parameters

2 weeks

Multiple visits (in-person and phone calls)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Visits at day 6, day 14, and week 6

Treatment Details

Interventions

• surgical approach

Trial Overview The study compares two surgical approaches for hip repair after a fracture: the Direct Anterior Approach (front of the hip) versus the Lateral approach (side of the hip), focusing on recovery speed and patient outcomes.

Participant Groups

Group I: Lateral approach for hemiarthroplasty Experimental Treatment 1 Intervention

Patients in this arm will receive a hemiarthroplasty using the lateral approach

Group II: Direct anterior approach for hemiarthroplasty Experimental Treatment 1 Intervention

Patients in this arm will receive a hemiarthroplasty using the direct anterior approach (DAA)

surgical approach is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Direct Anterior Approach for:

• Femoral neck fracture repair
• Hip arthroplasty

Approved in European Union as Direct Anterior Approach for:

• Femoral neck fracture repair
• Hip arthroplasty

Approved in Japan as Direct Anterior Approach for:

• Femoral neck fracture repair
• Hip arthroplasty

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Findings from Research

The Direct Anterior Approach (DAA) for hip replacement may lead to less soft tissue damage compared to the Lateral Approach (LA), potentially resulting in improved postoperative mobility and fewer complications for elderly patients with displaced femoral neck fractures.

This study will evaluate 138 patients to compare hip function, complications, and recovery outcomes between the two surgical approaches, aiming to identify which method optimizes recovery and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective comparison of the anterior and lateral approach in hemiarthroplasty for hip fractures: a study protocol. van der Sijp, MPL., Schipper, IB., Keizer, SB., et al.[2018]

In a study of 59 active elderly patients with displaced femoral neck fractures, those who underwent total hip arthroplasty using the direct anterior approach (DAA) had significantly better outcomes, including a higher Harris hip score at 6 weeks compared to those who had the direct lateral approach (DLA).

Patients in the DAA group also experienced a shorter hospital stay, averaging 4.2 days compared to 6.8 days for the DLA group, suggesting that DAA may lead to faster recovery and potentially lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Anterior vs. Direct Lateral Approach Total Hip Arthroplasty for Displaced Femoral Neck Fracture. Ben Elyahu, R., Ohana, N., Agabaria, E., et al.[2023]

The direct anterior approach (DAA) for total hip arthroplasty (THA) in patients with femoral neck fractures is associated with a significantly lower risk of 90-day dislocation, mechanical revision, and mortality compared to the posterior approach (PA), based on a study of 622 THAs.

While the DAA showed higher in-hospital medical complications, it resulted in better long-term outcomes, suggesting that experienced surgeons should consider this approach to reduce postoperative risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Anterior Approach Total Hip Arthroplasty Is Associated With Reduced 1-Year Mortality and Surgical Complications After Femoral Neck Fracture. Cichos, KH., McGwin, G., Boyd, B., et al.[2023]

The direct anterior approach (DAA) for total hip arthroplasty (THA) resulted in significantly lower pain levels and total blood loss compared to the lateral approach (LA), based on a meta-analysis of 5 randomized controlled trials involving 475 patients.

Patients undergoing DAA also showed improved walking velocity, stride length, and step length, indicating better functional recovery, although there were no significant differences in overall hip function scores or complication rates between the two approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct anterior versus lateral approaches for clinical outcomes after total hip arthroplasty: a meta-analysis. Wang, Z., Bao, HW., Hou, JZ.[2020]

In a study of 34 elderly patients (average age 82.68 years) undergoing bipolar hemiarthroplasty via the direct anterior approach (DAA), the procedure demonstrated a mean operation time of 83.5 minutes and minimal blood loss (263.53 mL), indicating it is a safe surgical option.

The DAA technique resulted in no cases of infection, dislocation, or reoperation, and patients were able to begin weight-bearing walking just 3 days post-surgery, suggesting effective recovery and stability in the treatment of unstable femoral intertrochanteric fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemiarthroplasty through Direct Anterior Approach for Unstable Femoral Intertrochanteric Fractures in the Elderly: Analysis of Early Cases. Park, JH., Chung, YY., Baek, SN., et al.[2022]

The direct anterior approach (DAA) for total hip arthroplasty (THA) shows a low risk incidence (RI) for dislocation (0.6%) and comparable rates of other complications to traditional THA methods, indicating its safety profile is similar overall.

However, the DAA is associated with specific risks, such as intra-operative trochanter and femoral fractures (0.8% and 0.5%, respectively) and transient lateral cutaneous femoral nerve impairment (0.9%), suggesting that the technique may require a learning curve for surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects associated with the direct anterior approach for total hip arthroplasty: a Bayesian meta-analysis. De Geest, T., Fennema, P., Lenaerts, G., et al.[2022]

In a study of 270 patients who underwent direct anterior approach (DAA) hip replacements, there was a notable incidence of complications, including a 10% rate of revision surgeries due to issues like dislocations and leg-length discrepancies.

The study also found that 21% of patients reported symptoms of lateral femoral cutaneous nerve injury, suggesting that while DAA may offer early recovery benefits, the potential for complications warrants cautious consideration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior approach to hip replacement and associated complications: an independent review. Vasantharao, P., Fenbury, D., Khan, R., et al.[2023]

In a study of 180 elderly patients undergoing Bipolar Hip Hemiarthroplasty using a modified Direct Anterior Approach, the rate of major complications was low, with only 10% developing pneumonia and a 1.7% mortality rate during hospitalization.

The modified DAA allowed for rapid mobilization, with 88.3% of patients able to use walkers or crutches, and 83% discharged to their usual social environment, indicating high patient satisfaction and effective rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of femoral neck fracture with a minimal invasive surgical approach for hemiarthroplasty - clinical and radiological results in 180 geriatric patients. Unger, AC., Dirksen, B., Renken, FG., et al.[2022]

The posterior approach (PA) for hemiarthroplasty in proximal femoral fractures is associated with a significantly higher risk of dislocations and reoperations compared to the anterior approach (AA) and lateral approach (LA), suggesting it may not be the best option for this procedure.

No significant differences were found in terms of perioperative fractures, wound infections, or hospital length of stay among the different approaches, indicating that while the PA has higher risks, it does not necessarily lead to worse overall recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Approaches and Hemiarthroplasty Outcomes for Femoral Neck Fractures: A Meta-Analysis. van der Sijp, MPL., van Delft, D., Krijnen, P., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Prospective comparison of the anterior and lateral approach in hemiarthroplasty for hip fractures: a study protocol. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Direct Anterior vs. Direct Lateral Approach Total Hip Arthroplasty for Displaced Femoral Neck Fracture. [2023]

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

Direct Anterior Approach Total Hip Arthroplasty Is Associated With Reduced 1-Year Mortality and Surgical Complications After Femoral Neck Fracture. [2023]

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

Direct anterior versus lateral approaches for clinical outcomes after total hip arthroplasty: a meta-analysis. [2020]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Hemiarthroplasty through Direct Anterior Approach for Unstable Femoral Intertrochanteric Fractures in the Elderly: Analysis of Early Cases. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Adverse effects associated with the direct anterior approach for total hip arthroplasty: a Bayesian meta-analysis. [2022]

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

Anterior approach to hip replacement and associated complications: an independent review. [2023]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Treatment of femoral neck fracture with a minimal invasive surgical approach for hemiarthroplasty - clinical and radiological results in 180 geriatric patients. [2022]

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

Surgical Approaches and Hemiarthroplasty Outcomes for Femoral Neck Fractures: A Meta-Analysis. [2022]