Comparison of MIS Anterior Versus MIS Anterolateral Approach

Osteoarthritis of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02458144
• Other study ID #: 1392/2012
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2015
• Last updated: May 28, 2015
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Medical University of Vienna
• Contact: Christoph Stihsen, Registrar
• Phone: 00431 40400
• Email: christoph.stihsen[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis of the Hip
• Osteoarthritis, Hip

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Austria	Department of Orthopaedics	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI evaluation	Cross-sectional area of gluteus medius and tensor fascia latae muscle (cm2)	12 months after surgery	No
Secondary	Harris Hip Score	Points (0-100)	12 months after surgery	No
Secondary	Tendon defects of the hip abductors (cm) assessed by Ultrasound	Tendon defects of the hip abductors (cm)	12 months after surgery	No
Secondary	Gait analysis	posture of the pelvis, hip strength, range of motion	12 months after surgery	No
Secondary	Serum trauma marker 1	creatinkinase (u/l)	1 hour preop. to 48 hours postop.	No
Secondary	Serum trauma marker 2	interleukin-6 (pg/ml)	1 hour preop. to 48 hours postop.	No
Secondary	Serum trauma marker 3	interleukin-1ß (pg/ml)	1 hour preop. to 48 hours postop.	No
Secondary	Serum trauma marker 4	lactate Dehydrogenase (u/l)	1 hour preop. to 48 hours postop.	No
Secondary	Serum trauma marker 5	aldolase (u/l)	1 hour preop. to 48 hours postop.	No
Secondary	Serum trauma marker 6	Myoglobin (ng/ml)	1 hour preop. to 48 hours postop.	No
Secondary	Serum trauma marker 7	malondialdehyde (mg/dl)	1 hour preop. to 48 hours postop.	No
Secondary	Serum trauma marker 8	glutathione (mg/dl)	1 hour preop. to 48 hours postop.	No