Comparison of MIS Anterior Versus MIS Anterolateral Approach

Not Applicable

• Conditions: Osteoarthritis of the Hip
• Interventions: Procedure: Total hip arthroplasty

• Registration Number: NCT02458144
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2015-05
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-05-28
• Last Update Submitted: 2015-05-28
• Study First Posted: 2015-05-29
• Last Update Posted: 2015-05-29
• Primary Completion: 2016-08
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIS "anterior" group	Total hip arthroplasty	Total Hip Arthroplasty "anterior" surgical approach
MIS "anterolateral" group	Total hip arthroplasty	Total Hip Arthroplasty "anterolateral" surgical approach

Primary Outcome Measures

Name	Time	Method
MRI evaluation	12 months after surgery	Cross-sectional area of gluteus medius and tensor fascia latae muscle (cm2)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Orthopaedics; 🇦🇹 Vienna, Austria