Comparison of MIS Anterior Versus MIS Anterolateral Approach

Sponsor
Medical University of Vienna (Other)
Overall Status
Unknown status
CT.gov ID
NCT02458144
Collaborator
(none)
40
1
2
47
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Total hip arthroplasty
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Aug 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: MIS "anterior" group

Total Hip Arthroplasty "anterior" surgical approach

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.

Other: MIS "anterolateral" group

Total Hip Arthroplasty "anterolateral" surgical approach

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.

Outcome Measures

Primary Outcome Measures

  1. MRI evaluation [12 months after surgery]

    Cross-sectional area of gluteus medius and tensor fascia latae muscle (cm2)

Secondary Outcome Measures

  1. Harris Hip Score [12 months after surgery]

    Points (0-100)

  2. Tendon defects of the hip abductors (cm) assessed by Ultrasound [12 months after surgery]

    Tendon defects of the hip abductors (cm)

  3. Gait analysis [12 months after surgery]

    posture of the pelvis, hip strength, range of motion

  4. Serum trauma marker 1 [1 hour preop. to 48 hours postop.]

    creatinkinase (u/l)

  5. Serum trauma marker 2 [1 hour preop. to 48 hours postop.]

    interleukin-6 (pg/ml)

  6. Serum trauma marker 3 [1 hour preop. to 48 hours postop.]

    interleukin-1β (pg/ml)

  7. Serum trauma marker 4 [1 hour preop. to 48 hours postop.]

    lactate Dehydrogenase (u/l)

  8. Serum trauma marker 5 [1 hour preop. to 48 hours postop.]

    aldolase (u/l)

  9. Serum trauma marker 6 [1 hour preop. to 48 hours postop.]

    Myoglobin (ng/ml)

  10. Serum trauma marker 7 [1 hour preop. to 48 hours postop.]

    malondialdehyde (mg/dl)

  11. Serum trauma marker 8 [1 hour preop. to 48 hours postop.]

    glutathione (mg/dl)

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Orthopaedics Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Study Chair: Reinhard Windhager, Chairman, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Christoph Stihsen, Dr. med. univ., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02458144
Other Study ID Numbers:
  • 1392/2012
First Posted:
May 29, 2015
Last Update Posted:
May 29, 2015
Last Verified:
May 1, 2015
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 29, 2015