Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
29/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stephen Attfield

ORCID ID

Contact details

Derby Hospitals NHS Foundation Trust
Bioengineering Research Centre
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes