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Is residual soft tissue imbalance following total knee replacement surgery a precursor to biomechanical failure? A prospective study

Is residual soft tissue imbalance following total knee replacement surgery a precursor to biomechanical failure? A prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78522557
Enrollment
84
Registered
2006-09-29
Start date
2005-06-14
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery: Total knee replacement (TKR) Surgery Total knee replacement (TKR)

Interventions

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

Sponsors

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026