Condition category
Musculoskeletal Diseases
Date applied
12/08/2010
Date assigned
08/10/2010
Last edited
02/06/2015
Prospective/Retrospective
Prospectively 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

Dr Anthony Redmond

ORCID ID

Contact details

Leeds Institute for Molecular Medicine
Section of Musculoskeletal Disease
2nd Floor
Chapel Allerton Hospital
Harehills Lane
Leeds
LS7 4SA
United Kingdom

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

http://www.leeds.ac.uk/

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

Publication citations

Additional files

Editorial Notes