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Comparison of MIS Anterior Versus MIS Anterolateral Approach

Primary Purpose

Osteoarthritis of the Hip

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Total hip arthroplasty
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Hip

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of OrthopaedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

MIS "anterior" group

MIS "anterolateral" group

Arm Description

Total Hip Arthroplasty "anterior" surgical approach

Total Hip Arthroplasty "anterolateral" surgical approach

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Harris Hip Score
Points (0-100)
Tendon defects of the hip abductors (cm) assessed by Ultrasound
Tendon defects of the hip abductors (cm)
Gait analysis
posture of the pelvis, hip strength, range of motion
Serum trauma marker 1
creatinkinase (u/l)
Serum trauma marker 2
interleukin-6 (pg/ml)
Serum trauma marker 3
interleukin-1β (pg/ml)
Serum trauma marker 4
lactate Dehydrogenase (u/l)
Serum trauma marker 5
aldolase (u/l)
Serum trauma marker 6
Myoglobin (ng/ml)
Serum trauma marker 7
malondialdehyde (mg/dl)
Serum trauma marker 8
glutathione (mg/dl)

Full Information

First Posted
May 26, 2015
Last Updated
May 28, 2015
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02458144
Brief Title
Comparison of MIS Anterior Versus MIS Anterolateral Approach
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIS "anterior" group
Arm Type
Other
Arm Description
Total Hip Arthroplasty "anterior" surgical approach
Arm Title
MIS "anterolateral" group
Arm Type
Other
Arm Description
Total Hip Arthroplasty "anterolateral" surgical approach
Intervention Type
Procedure
Intervention Name(s)
Total hip arthroplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRI evaluation
Description
Cross-sectional area of gluteus medius and tensor fascia latae muscle (cm2)
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Harris Hip Score
Description
Points (0-100)
Time Frame
12 months after surgery
Title
Tendon defects of the hip abductors (cm) assessed by Ultrasound
Description
Tendon defects of the hip abductors (cm)
Time Frame
12 months after surgery
Title
Gait analysis
Description
posture of the pelvis, hip strength, range of motion
Time Frame
12 months after surgery
Title
Serum trauma marker 1
Description
creatinkinase (u/l)
Time Frame
1 hour preop. to 48 hours postop.
Title
Serum trauma marker 2
Description
interleukin-6 (pg/ml)
Time Frame
1 hour preop. to 48 hours postop.
Title
Serum trauma marker 3
Description
interleukin-1β (pg/ml)
Time Frame
1 hour preop. to 48 hours postop.
Title
Serum trauma marker 4
Description
lactate Dehydrogenase (u/l)
Time Frame
1 hour preop. to 48 hours postop.
Title
Serum trauma marker 5
Description
aldolase (u/l)
Time Frame
1 hour preop. to 48 hours postop.
Title
Serum trauma marker 6
Description
Myoglobin (ng/ml)
Time Frame
1 hour preop. to 48 hours postop.
Title
Serum trauma marker 7
Description
malondialdehyde (mg/dl)
Time Frame
1 hour preop. to 48 hours postop.
Title
Serum trauma marker 8
Description
glutathione (mg/dl)
Time Frame
1 hour preop. to 48 hours postop.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Stihsen, Registrar
Phone
00431 40400
Ext
40820
Email
christoph.stihsen@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Bernd Kubista, Consultant
Phone
00431 40400
Ext
40820
Email
bernd.kubista@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhard Windhager, Chairman
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthopaedics
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Stihsen, Registrar
Phone
0140400
Ext
40820
Email
christoph.stihsen@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Bernd Kubista, Consultant
Phone
0140400
Ext
40820
Email
bernd.kubista@meduniwien.ac.at

12. IPD Sharing Statement

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Comparison of MIS Anterior Versus MIS Anterolateral Approach

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