Investigator Initiated Depuy Replacement knee In-Vivo Evaluation Study

ISRCTN	ISRCTN26541777
DOI	https://doi.org/10.1186/ISRCTN26541777
Secondary identifying numbers	Version 1.1

Submission date: 12/08/2010
Registration date: 08/10/2010
Last edited: 04/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anthony Redmond
Scientific

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

Study information

Study design	Post-operative comparator randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	DRIVE
Study objectives	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(s)	Leeds West Research Ethics Committee, 01/02/2010, ref: 09/H1307/103
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2010
Completion date	30/09/2012

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Both
Target number of participants	40
Key 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
Key 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
Date of first enrolment	01/11/2010
Date of final enrolment	30/09/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Leeds Institute for Molecular Medicine

Leeds
LS7 4SA
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Industry

DePuy International Limited (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

04/10/2017: No publications found in PubMed, verifying study status with principal investigator.