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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 22 May 2017
Main ID:  ACTRN12617000671369
Date of registration: 09/05/2017
Prospective Registration: Yes
Primary sponsor: University of Physical Education in Krakow
Public title: Influence of the use of frontal surgical access on biomechanical gait image and functional outcome of the lower limb in patients after hip arthroplasty
Scientific title: Influence of the use of frontal surgical access on biomechanical gait image and functional outcome of the lower limb in patients after hip arthroplasty
Date of first enrolment: 15/05/2017
Target sample size: 60
Recruitment status: Not yet recruiting
URL:  http://www.anzctr.org.au/ACTRN12617000671369.aspx
Study type:  Interventional
Study design:  Randomised controlled trial 
Phase: 
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
coxarthrosis
Intervention(s)
The purpose of the study will be to assess the impact of frontal, intra-muscular operating access on the biomechanical gait image and the functional outcome of the lower limb in patients after hip replacement.

The alternative solution for lateral access that is gaining an increasing number of followers is minimally invasive access from the frontal accession.
Minimally invasive access is defined as the absence of muscle and / or bone damage combined with short cutaneous cut. Minimally invasive does not mean a short scar, but as little damage to soft tissues, especially muscles and their attachment. Muscle protection accelerates movement improvement, allowing for a faster discharge from the surgical ward
The advantage of front access is the maintenance of undamaged muscles and their attachment to the pelvis and femur. This access uses the space between the iliotibial band and the gluteus medius. This allows them to return to their correct tension immediately after the operation. No damage to muscles and their attachment increases the dynamic, muscular stabilization of the operated hip.

The qualification for research will be based on the simple randomisation of research group. Allocation of patients to the research group will be decided upon the coin-tossing. Heads – patient is participating in the research, tails – patient does not take part in the research.
After the surgery, patients were randomly divided into two groups. Patients for particular groups will be always qualified by the same person - first researcher.
The first group is the patients who will have a frontal, intramuscular operation access during surgery, while the second group will have lateral surgical access.

The first test session will take place one week before the procedure. After 6 and 12 weeks, the examination will be re-performed.

All procedures will be carried out by first researcher. Surgery will be performed by orthopaedic surgeon

Research will include:
1. Analysis of the medical documentation of the patient.
2. Measurement of kinematic and kinetic parameters of gait based on three-dimensional motion analysis using the BTS Smart system in conjunction with the torque platform. The analysis will include:
- angular changes in the three planes of knee, hip, and ankle joints,
- changes in the length of selected muscles,
- changes in ground-reaction forces
- time-spatial parameters: number of steps per minute, time of single and double support, length and duration of full cycle, and speed of walk.
3. Registration of biopotentialities arising in the gluteus muscles (bilateral for maximus and medium gluteus muscles).
Duration of the surgical procedure: 2 hours
Overall duration of the assessments – 2 hours:
1. 1 hour for clinical examination,
2. 1 hour for gait and EMG test,
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
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Date Completed:
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