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Trials / Unknown

UnknownNCT02458144

Comparison of MIS Anterior Versus MIS Anterolateral Approach

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Medical University of Vienna · Academic / Other
Sex
All
Age
50 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETotal hip arthroplastyThe 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.

Timeline

Start date
2013-01-01
Primary completion
2016-08-01
Completion
2016-12-01
First posted
2015-05-29
Last updated
2015-05-29

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT02458144. Inclusion in this directory is not an endorsement.