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Trial registered on ANZCTR


Registration number
ACTRN12612001291875
Ethics application status
Approved
Date submitted
4/12/2012
Date registered
13/12/2012
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of preoperative and postoperative hamstring stretches on knee range of motion (ROM), Knee Extension Angle (KEA) and fixed flexion deformity after total knee arthroplasty
Scientific title
In individuals with hamstring tightness and varus and/or flexion deformity undergoing total knee arthroplasty
how does additional preoperative and postoperative hamstring stretching
compared with standard postoperative physical therapy
effect knee range of motion, knee extension angle, fixed flexion deformity, gait mechanics and patient outcomes.
Secondary ID [1] 281608 0
Australia Online Forms for Research AU/1/2A3C010
Universal Trial Number (UTN)
U1111-1127-2356
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 285591 0
hamstring tightness 285592 0
varus and or flexion deformity 285593 0
total knee arthroplasty 285594 0
Condition category
Condition code
Musculoskeletal 285791 285791 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preoperative and postoperative hamstring stretches.
Two, 2 min stretches twice daily for 4 weeks prior to total knee arthroplasty and for 6 weeks after total knee arthroplasty. Participants will be all be instructed in this exercise by a senior musculoskeletal physiotherapist at commencement in a one on one session and will recieve and instructional video on a DVD or USB drive. Participants will receive an exercise log and reminder text messages twice weekly. Accompanied by otherwise routine postoperative rehabilitation protocol after surgery (quadriceps and extension control, flexion range of motion, gait patterning, oedema control, deep venous thrombosis (DVT) prevention) to be done twice daily for 15 minutes immediately following the hamstring exercise.
Intervention code [1] 284043 0
Rehabilitation
Comparator / control treatment
Control exercise: Three, 20 second 10cm high straight leg raises twice daily for 4 weeks prior to total knee arthroplasty and for 6 weeks after total knee arthroplasty.Accompanied by otherwise routine postoperative rehabilitation protocol (quadriceps and extension control, flexion range of motion, gait patterning, oedema control, deep venous thrombosis (DVT) prevention)
Control group
Active

Outcomes
Primary outcome [1] 286300 0
Knee extension angle. A clinical measurement made with the participant passive and lying supine. The thigh in flexed to 90degrees by the examiner with the contralateral lower limb fully extended to keep the pelvis level. With the thigh maintained at the 90 degree position the knee is then passively extended until a point of elastic resistance or discomfort is reached. The acute angle subtended by the line of the thigh and the line of the leg is the knee extension angle. Measured using the digital level (thigh flexion) and digital inclinometer (knee extension angle) functions of the Angulus ROM iPhone application.
Timepoint [1] 286300 0
baseline, 4 weeks (immediately prior to total knee arthroplasty), 10 weeks (6 weeks after total knee arthroplasty), 30 weeks (6 months after total knee arthroplasty)
Primary outcome [2] 286301 0
Knee range of motion.A clinical measurement made with the participant active and lying supine. The participant fully extends the knee with a forceful quadriceps contraction whilst lying supine. The acute angle made between the line of the thigh and the line of the leg is measured (extension range).The participant then fully flexes the knee with whilst lying supine. The acute angle made between the line of the thigh and the line of the leg is measured (flexion range). Extension range is subtracted from flexion range to give range of motion. Measured using digital inclinometer of the Angulus ROM iPhone application.
Timepoint [2] 286301 0
baseline, 4 weeks (immediately prior to total knee arthroplasty), 10 weeks (6 weeks after total knee arthroplasty), 30 weeks (6 months after total knee arthroplasty)
Primary outcome [3] 286302 0
Gait mechanics (EMG, force plate, optical).
1. EMG (Electromyogram). Timing and magnitude of quadriceps and hamstring activation.
2. Force Plate. Gait cadence, speed, symmetry, step length, contact patterns
3. Optics. Limb segment motion with particular emphasis on use of available knee extension range of motion during gait.
Timepoint [3] 286302 0
baseline, 4 weeks (immediately prior to total knee arthroplasty), 10 weeks (6 weeks after total knee arthroplasty)
Secondary outcome [1] 295563 0
Patient outcome (validated outcome scores)
EQ-5D, KOOS (WOMAC), Oxford Knee Score, Knee Society Score.
Timepoint [1] 295563 0
baseline, 4 weeks (immediately prior to total knee arthroplasty), 10 weeks (6 weeks after total knee arthroplasty), 30 weeks (6 months after total knee arthroplasty)

Eligibility
Key inclusion criteria
1. A diagnosis of advanced symptomatic knee osteoarthritis with varus, flexion or flexion and varus deformities >=10 degrees in any one plane in individuals fit for and requiring total knee arthroplasty (TKA).
2. Hamstring tightness (Knee Extension Angle (KEA) >40o .with or without symptomatic pes anserinus bursitis (PAB).
3. The ability and willingness to engage a preoperative and postoperative hamstring stretching program.
Minimum age
45 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A leg length discrepancy is greater or equal to three cm.
2. Ipsilateral hip / ankle ankylosis or arthrodesis.
3. Ipsilateral fixed flexion deformities of the hip or ankle on the same limb.

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)
Potential participants will be identified from those referred to participating orthopaedic surgeons for treatment of advanced symptomatic knee osteoarthritis. Participants will be give a verbal and written explanation of the trial and written informed consent will be obtained. Participants will be randomised (sealed envelopes) and allocation of randomization will be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online random number generator. Blinded allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 306 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 6072 0
4810
Recruitment postcode(s) [2] 6070 0
4812
Recruitment postcode(s) [3] 6071 0
4814
Recruitment postcode(s) [4] 6073 0
4817
Recruitment postcode(s) [5] 6074 0
4818

Funding & Sponsors
Funding source category [1] 284543 0
Charities/Societies/Foundations
Name [1] 284543 0
The Townsville Hospital Private Practice Research Trust
Address [1] 284543 0
Angus Smith Drive
Douglas 4814 Qld.
Country [1] 284543 0
Australia
Funding source category [2] 284544 0
Other
Name [2] 284544 0
The ORIQL (Orthopaedic Research Institute of Queensland)
Address [2] 284544 0
Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld
Country [2] 284544 0
Australia
Primary sponsor type
Other
Name
The ORIQL (Orthopaedic Research Institute of Queensland)
Address
Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld
Country
Australia
Secondary sponsor category [1] 283527 0
Individual
Name [1] 283527 0
Dr Peter McEwen
Address [1] 283527 0
Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico QLD 4812
Country [1] 283527 0
Australia
Other collaborator category [1] 277205 0
University
Name [1] 277205 0
James Cook University (Motion Analysis Laboratory)
Address [1] 277205 0
1 James Cook Dve
Douglas 4814 QLD
Country [1] 277205 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286603 0
Mater Hospital Townsville Ethics Committee
Ethics committee address [1] 286603 0
Mater Hospital Townsville
21-37 Fulham Rd
Pimlico QLD 4810
Ethics committee country [1] 286603 0
Australia
Date submitted for ethics approval [1] 286603 0
27/01/2012
Approval date [1] 286603 0
15/03/2012
Ethics approval number [1] 286603 0
EC00412
Ethics committee name [2] 288491 0
James Cook University
Ethics committee address [2] 288491 0
1 James Cook Dve
Douglas 4814 QLD
Ethics committee country [2] 288491 0
Australia
Date submitted for ethics approval [2] 288491 0
Approval date [2] 288491 0
15/03/2012
Ethics approval number [2] 288491 0
EC00164

Summary
Brief summary
Hamstring tightness and insertional tendonopathy is a common condition that frequently coexists with osteoarthritis about the knee. Total knee arthroplasty (TKA) is the definitive treatment of advanced symptomatic knee ostoearthritis but does nothing to treat hamstring tightness and insertional tendonopathy which can then interfere with the recovery from TKA by causing pain and altering gait mechanics. Little data exists on the coexistence of these two conditions however. The author proposes a prospective randomized blinded trial to assess the effect of hamstring stretching on knee extension angle,gait, fixed flexion deformity and symptoms in the osteoarthritic knee and to assess the effect of hamstring stretching the same parameters after TKA. Patients presenting to participating orthopaedic surgeons for treatment of knee osteoarthritis with flexion, varus or flexion and varus deformity >= 10 degrees and scheduled for TKA will be eligible for enrollment in the study. Clinical assessment of the knee, gait analysis and validated outcomes scores to be assessed at time zero, after four weeks of stretching and six weeks after TKA. Final examination and scoring at 6 months post op. Symptoms to be assessed using standardized assessment forms (Euroqual, WOMAC, Oxford Knee Score, Knee Society Knee Score, KOOS). Unilateral TKA participants will be randomly allocated to either a control (CTKA) or treatment (TTKA). Bilateral TKA patients will also be randomly allocated to either a control (CTKA) or treatment (TTKA).The TTKA treatment groups will undergo a stretching program 4 weeks before and 6 weeks after TKA surgery. The Participants will be instructed in performing a hamstring stretch by a physiotherapist. Participants will be required to perform a 2 x 2 mins progressive hamstring stretches twice daily (total of 8 min hamstring stretch on each leg). Instruction video to be provided to each patient on portable USB drive. Reminder text messages twice weekly to be sent. Gait lab technician and clinical assessor and inpatient physiotherapist to be blinded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33638 0
Dr Peter McEwen
Address 33638 0
The Orthopaedic Research Institute of Qld
Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 QLD
Country 33638 0
Australia
Phone 33638 0
+61747550564
Fax 33638 0
Email 33638 0
peter@kneesurgeon.com.au
Contact person for public queries
Name 16885 0
Mrs Andrea Grant
Address 16885 0
The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld
Country 16885 0
Australia
Phone 16885 0
+61413685331
Fax 16885 0
Email 16885 0
research_coordinator@oriql.com.au
Contact person for scientific queries
Name 7813 0
Mrs Andrea Grant
Address 7813 0
The Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld
Country 7813 0
Australia
Phone 7813 0
+61413685331
Fax 7813 0
Email 7813 0
research_coordinator@oriql.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our research group has not yet come to an agreement on what data will be made available and on what platform we will be making this data available. We would like to include this information in the patient's consent before making their IPD available. This is in the process of being discussed.
What supporting documents are/will be available?
No other documents available
Summary results
No Results