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Trial registered on ANZCTR


Registration number
ACTRN12617000671369
Ethics application status
Approved
Date submitted
3/04/2017
Date registered
9/05/2017
Date last updated
9/05/2017
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 291601 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coxarthrosis 302715 0
Condition category
Condition code
Musculoskeletal 302236 302236 0 0
Osteoarthritis
Surgery 302237 302237 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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,
Intervention code [1] 297672 0
Treatment: Surgery
Comparator / control treatment
One access that is common and very often used is the lateral access. This is one of the most commonly access used in hip joints. It leads between the gluteus medius muscles and the frontal margin of the gluteus maximus and allows for quick access to the joint. In turn, the disadvantage of lateral access is the dissection of the gluteus medius and minimus muscles from the femur, and any damage to the musculature and its attachment is associated with weakening of its strength and damage to its prioreceptors.

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. 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.
2. Registration of biopotentialities arising in the gluteus muscles (bilateral for large and medium gluteus muscles).

Patients for particular groups will be always qualified by the same person - first researcher.
Duration of the surgical procedure - 2 hours
Overall duration of the assessments for lateral access – 2 hours:
1. 1 hour for clinical examination,
2. 1 hour for gait and EMG test,

The results of the healthy control group will be used to refer the results of the study group to the results of healthy individuals, and thus to assess which operative approach enables better functional outcomes.

Research will include:
1. 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.
2. Registration of biopotentialities arising in the gluteus muscles (bilateral for large and medium gluteus muscles).

Patients for particular groups will be always qualified by the same person - first researcher.

Overall duration of the assessments– 1 hour:
1. 1 hour for gait and EMG test,
Control group
Active

Outcomes
Primary outcome [1] 301644 0
Muscle activity of gluteus maximus and gluteus medius assessed by EMG
Timepoint [1] 301644 0
before surgery and after 6 and 12 weeks after arthroplasty
Primary outcome [2] 301645 0
Kinematic parameters of gait assessed by BTS Smart System
Timepoint [2] 301645 0
before surgery and after 6 and 12 weeks after arthroplasty
Secondary outcome [1] 333425 0
Hip function, assessed using the WOMAC and Harris scale.
Timepoint [1] 333425 0
before surgery and after 6 and 12 weeks after arthroplasty

Eligibility
Key inclusion criteria
Eligibility criteria for the study group:
1. Requires hip replacement, as determined by the treating doctor for degenerative changes.
2. Ability to move independently before and after surgery (without orthopedic support),
3. No other locomotive organs or neurological diseases affecting the locomotion,
4. Written consent for participation in research

Control group:
1. Lack of injuries and diseases of the musculoskeletal system and neurological diseases.
2. Written consent of the patient to participate in research,
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Study and control group
1. Age below 40 and above 65 years
2. 30 < BMI <19
3. Identified coexisting diseases such. neurological, cardiac, advanced diabetes, uncontrolled high blood pressure and other diseases that may affect the gait pattern,
3. acute injuries and inflammation within the motor organs,
4. the overall poor health of the test,

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Statistical analysis of the collected material in the first stage will include testing the normal distribution of variables (Shapiro-Wilk test). Then, depending on the results of the calculated ratios are descriptive statistics such as the arithmetic mean (x) and standard deviation (s) or median and deviation quadrant.
517/5000
Depending on the distribution of the variables for testing the significance of differences between mean values of the variables will be used analysis of variance [ANOVA (F test) verification by test post hoc Tukey, or in the absence of normal distribution of results, the non-parametric test for two dependent samples (Wilcoxon test ).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2017
Actual
Date of last participant enrolment
Anticipated
31/01/2018
Actual
Date of last data collection
Anticipated
31/01/2018
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 8774 0
Poland
State/province [1] 8774 0
Malopolska

Funding & Sponsors
Funding source category [1] 296089 0
University
Name [1] 296089 0
University of Physical Education in Krakow
Country [1] 296089 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow
Address
University of Physical Education in Krakow
Al. Jan Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 294985 0
None
Name [1] 294985 0
None
Address [1] 294985 0
None
Country [1] 294985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297345 0
Bioethics Commission at the Regional Medical Chamber in Krakow
Ethics committee address [1] 297345 0
Bioethics Commission at the Regional Medical Chamber in Krakow
ul. Krupnicza 11a
31-123 Krakow
Ethics committee country [1] 297345 0
Poland
Date submitted for ethics approval [1] 297345 0
01/03/2017
Approval date [1] 297345 0
14/03/2017
Ethics approval number [1] 297345 0
44/KBL/OIL/2017

Summary
Brief summary
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 studies will involve 60 patients aged 40-65 years, of both sexes, with coxarthrosis, qualified for hip replacement surgery.
The control group will be the healthy people, aged 40 - 65 years of both sexes.
Patients will be divided into two research groups. The first group is the patients who will have a frontal intramuscular operation during surgery, while the second group will have side-access surgery.
The first research session will take place one week before the procedure. Each patient will have a locomotive test combined with EMG registration. Each patient will also have a functional test (measurement of range of motion).The Harris and WOMAC scales will also be used.
After 6 and 12 weeks, locomotion test, EMG registration and clinical scale scans will be performed again.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1617 1617 0 0
/AnzctrAttachments/372677-bioethics approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 73766 0
Dr Katarzyna Ogrodzka
Address 73766 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 73766 0
Poland
Phone 73766 0
+48126831065
Fax 73766 0
Email 73766 0
katarzyna.ogrodzka@awf.krakow.pl
Contact person for public queries
Name 73767 0
Dr Katarzyna Ogrodzka
Address 73767 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 73767 0
Poland
Phone 73767 0
+48126831065
Fax 73767 0
Email 73767 0
katarzyna.ogrodzka@awf.krakow.pl
Contact person for scientific queries
Name 73768 0
Dr Katarzyna Ogrodzka
Address 73768 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 73768 0
Poland
Phone 73768 0
+48126831065
Fax 73768 0
Email 73768 0
katarzyna.ogrodzka@awf.krakow.pl

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No Supporting Document Provided



Results publications and other study-related documents

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