Comparison of MIS Anterior Versus MIS Anterolateral Approach

NCT ID: NCT02458144

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Osteoarthritis of the Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MIS "anterior" group

Total Hip Arthroplasty "anterior" surgical approach

Group Type: OTHER

Total hip arthroplasty

Intervention Type: PROCEDURE

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.

MIS "anterolateral" group

Total Hip Arthroplasty "anterolateral" surgical approach

Group Type: OTHER

Total hip arthroplasty

Intervention Type: PROCEDURE

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.

Interventions

Total 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Christoph Stihsen

Dr. med. univ.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reinhard Windhager, Chairman

Role: STUDY_CHAIR

Medical University of Vienna

Locations

Department of Orthopaedics

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Christoph Stihsen, Registrar

Role: CONTACT

Phone: 00431 40400

Email: christoph.stihsen@meduniwien.ac.at

Bernd Kubista, Consultant

Role: CONTACT

Phone: 00431 40400

Email: bernd.kubista@meduniwien.ac.at

Facility Contacts

Christoph Stihsen, Registrar

Role: primary

Bernd Kubista, Consultant

Role: backup

Other Identifiers

1392/2012

Identifier Type: -

Identifier Source: org_study_id