Minimally Invasive Surgery of the Hip Versus Standard Approach

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.

Detailed Description
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Traditional techniques for total hip arthroplasty (THA) require complete visualization of the acetabulum and proximal femur since anatomic landmarks are crucial for correct orientation of the prosthetic components. All surgeons are taught that a wide surgical exposure is one of the most important factors in performing successful THA. Traditionally, it was impossible to achieve accurate fixation and orientation of the components without complete visualization of bony landmarks. These extensile exposures facilitate accurate implant alignment, but at the expense of more extensive soft tissue dissection. Little clinical research has been undertaken to relate the surgical approach to postoperative complications or patient function. Furthermore, despite the good overall results of THA, the recovery time to improved function can be lengthy. Blood loss is expected to be directly related to the extent of the surgical exposure and to influence patients outcomes. Based upon these facts, an important principle of arthroplasty surgery is to minimize the amount of soft tissue trauma while being able to achieve the surgical goal of reconstructing the arthritic hip joint. By definition, minimally invasive surgical (MIS) procedures result in less soft tissue disruption, which in turn should reduce pain, expedite healing, decrease recovery time, and potentially reduce the number of associated complications.

Official Title
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Minimally Invasive Surgery of the Hip: A Randomized Study

Conditions
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Hip Arthroplasty, Osteoarthritis

Intervention / Treatment
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* Procedure: Minimally Invasive Surgery
* Procedure: Standard Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis Exclusion Criteria: Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc Rheumatoid Arthritis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Minimally Invasive Surgery (MIS)<br>In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her. | Procedure: Minimally Invasive Surgery<br>* In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.<br>|
| Sham Comparator: Standard Surgery<br>The standard way an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision | Procedure: Standard Surgery<br>* The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision.<br>* Other names: non applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes | Hospital length of stay | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Questionnaire to measure health outcome status. An index score of 100 is the highest score and is indicative of better outcome, while 0 is the lowest score and indicative of worse outcome. With regards to health, a score between 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor. | 24 months | 
| Change in Timed Get-up-and-Go Test (TUG) | A timed assessment to assess a participants mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. A faster time is indicative of better mobility, while a slower time is indicative of worse mobility. | 3 months | 
| Operating Time Duration | Duration of the surgical procedure | Day of Surgery | 
| Estimated Blood Loss | Estimated blood loss during the operative procedure | Day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Total Hip Arthroplasty, Minimally Invasive Surgery