Investigator Initiated Depuy Replacement knee In-Vivo Evaluation Study
| ISRCTN | ISRCTN26541777 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26541777 |
| Protocol serial number | Version 1.1 |
| Sponsor | University of Leeds (UK) |
| Funder | DePuy International Limited (UK) |
- 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
Scientific
Leeds Institute for Molecular Medicine
Section of Musculoskeletal Disease
2nd Floor, Chapel Allerton Hospital
Harehills Lane
Leeds
LS7 4SA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Post-operative comparator randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Maximum knee flexion measured using the Fastrak electromagnetic motion tracking system (Polhemus, USA) |
| Key secondary outcome measure(s) |
A comparison of high performance activities (sit to stand and squatting) 12 months after surgery |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Leeds Institute for Molecular Medicine
Leeds
LS7 4SA
United Kingdom
LS7 4SA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
