Comparison of MIS Anterior Versus MIS Anterolateral Approach

Study Overview
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Brief Summary
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Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS (minimally invasive surgery) anterior approach with the MIS anterolateral approach to the hip.

Detailed Description
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The surgical approach to the hip is reportedly an important factor influencing implant stability and postsurgical muscle functioning. Reviewing the literature, controversial studies towards minimally invasive hip surgery can be found. Currently, none of the approaches can be considered superior, but the trend is towards minimally invasive techniques, as it is generally accepted that muscle trauma and damage of the periarticular structures should be minimized. However, a surgical approach that causes no damage to surrounding muscle is unrealistic. Whether the muscle is stretched, transacted or partially torn, injury will occur. Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS anterior approach with the MIS anterolateral approach to the hip. The investigators questioned, which technique would be the less invasive? Pain and functional performance will be measured using the Harris Hip Score, the Western Ontario McMaster, and the UCLA (University of California) Activity Score. Subject quality-of-life will be determined by evaluation the Short-Form 36 Health Survey. Standard radiographs of the hip are required to be captured before surgery and at 3, 6 and 12 months postoperatively. MRI scans will be performed to evaluate tendon defects, fatty atrophy and changes in the muscle cross-sectional area. Next, the patients will be referred for hip sonography, performed by a radiologist who is experienced in imaging of the musculoskeletal system who will be unaware of the clinical examination results of the patients. Moreover gait analyses will be performed preoperatively, 3 and 12 months after surgery. Pre- and postoperative standard blood tests and specific serum trauma markers will be obtained.

Official Title
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Comparison of Two Minimally Invasive Approaches to the Hip-anterior Versus Anterolateral - Which Technique is Less Invasive? A Prospective, Randomized, Controlled Pilot Study

Conditions
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Osteoarthritis of the Hip

Intervention / Treatment
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* Procedure: Total hip arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral, noninflammatory end-stage osteoarthritis of the hip willingness and ability to cooperate in the required post-operative therapy willingness and ability to provide written informed consent age 50-80 years Exclusion Criteria: inflammatory arthropathies prior hip surgery prior infection of the hip severe morbidity severe osteoporosis inability to tolerate general anesthesia no contraindications to MRI e.g. pacemakers, claustrophobia neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care known alcohol or drug abuse unwillingness to participate

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MIS anterior group<br>Total Hip Arthroplasty anterior surgical approach | Procedure: Total hip arthroplasty<br>* The minimally invasive anterior approach The patient is in supine position. The femoral neck is exposed in the interval between tensor fasciae latae, glutei medius and minimus muscles laterally, and sartorius and rectus femoris muscles medially. After osteotomy of the neck and extraction of the head the acetabulum is reamed to prepare for cup prosthesis. Following peritrochanteric capsulotomy the externally rotated, adducted and elevated femur is broached. The MIS anterolateral approach The MIS anterolateral technique is a modified Watson-Jones Approach. The patient is in supine position. This approach uses the intermuscular plane between the gluteus medius and the tensor fascia latae. After the anterior capsule is excised, a disc of the femoral neck is removed.<br>|
| Other: MIS anterolateral group<br>Total Hip Arthroplasty anterolateral surgical approach | Procedure: Total hip arthroplasty<br>* The minimally invasive anterior approach The patient is in supine position. The femoral neck is exposed in the interval between tensor fasciae latae, glutei medius and minimus muscles laterally, and sartorius and rectus femoris muscles medially. After osteotomy of the neck and extraction of the head the acetabulum is reamed to prepare for cup prosthesis. Following peritrochanteric capsulotomy the externally rotated, adducted and elevated femur is broached. The MIS anterolateral approach The MIS anterolateral technique is a modified Watson-Jones Approach. The patient is in supine position. This approach uses the intermuscular plane between the gluteus medius and the tensor fascia latae. After the anterior capsule is excised, a disc of the femoral neck is removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI evaluation | Cross-sectional area of gluteus medius and tensor fascia latae muscle (cm2) | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Points (0-100) | 12 months after surgery | 
| Tendon defects of the hip abductors (cm) assessed by Ultrasound | Tendon defects of the hip abductors (cm) | 12 months after surgery | 
| Gait analysis | posture of the pelvis, hip strength, range of motion | 12 months after surgery | 
| Serum trauma marker 1 | creatinkinase (u/l) | 1 hour preop. to 48 hours postop. | 
| Serum trauma marker 2 | interleukin-6 (pg/ml) | 1 hour preop. to 48 hours postop. | 
| Serum trauma marker 3 | interleukin-1β (pg/ml) | 1 hour preop. to 48 hours postop. | 
| Serum trauma marker 4 | lactate Dehydrogenase (u/l) | 1 hour preop. to 48 hours postop. | 
| Serum trauma marker 5 | aldolase (u/l) | 1 hour preop. to 48 hours postop. | 
| Serum trauma marker 6 | Myoglobin (ng/ml) | 1 hour preop. to 48 hours postop. | 
| Serum trauma marker 7 | malondialdehyde (mg/dl) | 1 hour preop. to 48 hours postop. | 
| Serum trauma marker 8 | glutathione (mg/dl) | 1 hour preop. to 48 hours postop. |