Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.1
Study information
Scientific title
Investigator Initiated Depuy Replacement knee In-Vivo Evaluation Study: a post-operative comparator study characterising the in-vivo functional capacities of patients following total knee arthroplasty (TKA) after randomisation to one of two different implant types
Acronym
DRIVE
Study hypothesis
To compare the in-vivo function of the PFC sigma cruciate retaining (CR) implant with the PFC CR 150 at 3, 6 and 12 months post-operatively.
Ethics approval
Leeds West Research Ethics Committee, 01/02/2010, ref: 09/H1307/103
Study design
Post-operative comparator randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Osteoarthritis
Intervention
A total of 40 patients will be recruited to the study. These patients will undergo a range of baseline evaluations as appropriate to their presenting condition. These would include:
1. A routine musculoskeletal clinical examination (including assessment of presenting symptoms and clinical musculoskeletal functional tests)
2. Completion of relevant patient reported outcome instruments (36-item short form health survey [SF-36], Oxford knee score, Knee Injury and Osteoarthritis Outcome Score [KOOS], Knee Society Clinical Rating System [KSS])
3. Knee joint kinematics and kinetics measured using Vicon T series, Oxford Metrics Oxford UK
4. Functional measures to be undertaken include:
4.1. High flexion angle joint function measured using Fastrak electromagnetic motion tracking (Polhemus, USA)
4.2. High demand joint function (Sit to stand and squat) measured using Vicon T series (Oxford Metrics Oxford, UK)
A case/control design will be used to compare outcomes following surgery in patients receiving PFC sigma and CR150 implants. Patients will undergo the same range of evaluations as those described above at 3 months, 6 months and 1 year.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Maximum knee flexion measured using the Fastrak electromagnetic motion tracking system (Polhemus, USA)
Secondary outcome measures
A comparison of high performance activities (sit to stand and squatting) 12 months after surgery
Overall trial start date
01/11/2010
Overall trial end date
30/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients (no age limit, either sex) with osteoarthritis of the knee undergoing unilateral knee replacement at Chapel Allerton Orthopaedic Centre
2. Patients with a functionally normal contralateral knee
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Patients who cannot safely walk unaided
2. Patients who decline to give permission for their clinical data to be used in anonymised form for research purposes
3. Patients who are unable to give informed consent
Recruitment start date
01/11/2010
Recruitment end date
30/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Institute for Molecular Medicine
Leeds
LS7 4SA
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
DePuy International Limited (UK)
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