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ISRCTN
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ISRCTN78522557
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ClinicalTrials.gov identifier
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Public title
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Is residual soft tissue imbalance following TKR surgery a precursor to biomechanical failure? A prospective study
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0077161778
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Study hypothesis
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Does identification and reduction of contracted soft tissues surrounding the knee joint result in improved biomechanics of the knee joint, 6 months post operatively? Biomechanics of the knee can be used as an early indicator to prosthetic knee failure.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Surgery: Total knee replacement (TKR)
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Participants - inclusion criteria
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The population for this project will consist of 84 patients who have osteoarthritis of the knee and who have reached the top of the waiting list of one consultant orthopeadic surgeon at Derby Hospitals NHS Foundation Trust. The patients will be recruited to the study approximately two weeks prior to the planned date of surgery, during the standard pre-surgery screening. The recruitment process will be undertaken by the second investigator. The cohort size was determined with a power calculation.
Inclusion Criteria:
1. Patients who are having TKR surgery for osteoarthritis of the knee
2. Patients that are being treated by one consultant orthopaedic surgeon
3. Patients that are having unilateral or bilateral replacements
4. Patients that are having bilateral replacements at different operating centres
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Participants - exclusion criteria
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1. Patients that are having their knee replaced for rheumatoid arthritis, accident or septic cysts
2. Patients that have undergone previous surgery to the knee such as ligament reconstructions or femoral osteotomy wedges
3. Patients with any neurological, metabolic or vascular disease that might affect proprioceptive feedback mechanisms of the knee
4. Any patient or volunteers that have any other pathological problem that would affect their gait patterns, such as contra lateral amputation, or significant leg length discrepancy
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Anticipated start date
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14/06/2005
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Anticipated end date
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30/08/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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84
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Interventions
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The project subjects will be randomised in the strict order that they are recruited to the study using a standard randomisation table by the main investigator after recruitment to the study.
All of the patients will be treated according to standard operative procedures for total knee replacement surgery and will be fitted with a Genesis 2 surgical prosthesis by the treating consultant. Patients who are allocated to group A will have their soft tissue imbalance assessed by manual palpation of the joint by the surgeon. Group B will be assessed using the balancer/tensor (Stryker Howmedica Osteonics Allendale, HJ) technique of assessment. Soft tissue releases will be carried out on the basis of information available at the time of operation, that is, by observation, palpation and/or movement of the joint. Post operative care will be routine.
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Primary outcome measure(s)
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All of the patients will be assessed clinically using the WOMAC rating scale, during the preoperative assessment and six months post operatively by the second investigator. At the six months stage the biomechanics of the knee joint will be assessed in the Gait and Movement laboratory (Derbyshire Royal Infirmary). The patients will have a number of retro reflective markers positioned on their pelvis, thigh and tibia of the corresponding lower limb and will be asked to walk 10 meters on three separate occasions. The markers will be positioned and data collected by a third investigated. The following outcome measures will be used from the gait evaluations: knee varus/ valgus rotation, knee flexion/extension rotation, knee flexion/extension moment, knee abb/adduction moment.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Stephen
Attfield
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Address
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Derby Hospitals NHS Foundation Trust
Bioengineering Research Centre
Derbyshire Royal Infirmary
London Road
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City/town
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Derby
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Zip/Postcode
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DE1 2QY
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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14/11/2011
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Date ISRCTN assigned
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29/09/2006
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