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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02458144
Enrollment
40
Registered
2015-05-29
Start date
2013-01-31
Completion date
2016-12-31
Last updated
2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Hip

Brief 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.

Interventions

PROCEDURETotal hip arthroplasty

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.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MRI evaluation12 months after surgeryCross-sectional area of gluteus medius and tensor fascia latae muscle (cm2)

Secondary

MeasureTime frameDescription
Serum trauma marker 71 hour preop. to 48 hours postop.malondialdehyde (mg/dl)
Serum trauma marker 81 hour preop. to 48 hours postop.glutathione (mg/dl)
Serum trauma marker 31 hour preop. to 48 hours postop.interleukin-1β (pg/ml)
Serum trauma marker 41 hour preop. to 48 hours postop.lactate Dehydrogenase (u/l)
Serum trauma marker 51 hour preop. to 48 hours postop.aldolase (u/l)
Serum trauma marker 61 hour preop. to 48 hours postop.Myoglobin (ng/ml)
Tendon defects of the hip abductors (cm) assessed by Ultrasound12 months after surgeryTendon defects of the hip abductors (cm)
Gait analysis12 months after surgeryposture of the pelvis, hip strength, range of motion
Serum trauma marker 11 hour preop. to 48 hours postop.creatinkinase (u/l)
Serum trauma marker 21 hour preop. to 48 hours postop.interleukin-6 (pg/ml)
Harris Hip Score12 months after surgeryPoints (0-100)

Countries

Austria

Contacts

Primary ContactChristoph Stihsen, Registrar
christoph.stihsen@meduniwien.ac.at00431 40400
Backup ContactBernd Kubista, Consultant
bernd.kubista@meduniwien.ac.at00431 40400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026