Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077161778
Study information
Scientific title
Is residual soft tissue imbalance following total knee replacement surgery a precursor to biomechanical failure? A prospective study
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Total knee replacement (TKR)
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
14/06/2005
Overall trial end date
30/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
84
Participant exclusion criteria
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
Recruitment start date
14/06/2005
Recruitment end date
30/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary