Local JAVLIN Registry V1.0
Research type
Research Database
IRAS ID
161937
Contact name
Andrew Price
Contact email
Research summary
Local JAVLIN Registry - Joint Arthroplasty Validated InformatioN Registry
REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/1190
Date of REC Opinion
8 Sep 2014
REC opinion
Favourable Opinion
Data collection arrangements
We seek to establish a research database that will have the primary aim of monitoring the longterm
outcome of
patients undergoing hip and knee arthroplasty in this hospital. The creation of this database will allow us to obtain
longterm
high quality data that will facilitate research into the longterm
clinical outcomes following hip and knee
replacement surgery. Even though there is currently a wealth of shortterm
data on PROMs for patients undergoing hip
and knee replacement, the longterm
PROMs outcomes are less researched. The National Joint Registry (NJR)
traditionally collects and monitors longterm
data on implant survival, but only up to one year on PROMs. Few studies
have attempted to analyse long term PROMs outcomes, however these were done on datasets that did not have
sufficient followup
times or suffered from poor completion rates (13).
All documents will be stored securely and only accessible by staff and authorised personnel. The study will comply
NHS REC Research Database Form Reference:
14/SC/1190
IRAS Version 3.5
Date: 29/07/2014 4 161937/645662/9/732
We seek to establish a research database that will have the primary aim of monitoring the longterm
outcome of
patients undergoing hip and knee arthroplasty in this hospital. The creation of this database will allow us to obtain
longterm
high quality data that will facilitate research into the longterm
clinical outcomes following hip and knee
replacement surgery. Even though there is currently a wealth of shortterm
data on PROMs for patients undergoing hip
and knee replacement, the longterm
PROMs outcomes are less researched. The National Joint Registry (NJR)
traditionally collects and monitors longterm
data on implant survival, but only up to one year on PROMs. Few studies
have attempted to analyse long term PROMs outcomes, however these were done on datasets that did not have
sufficient followup
times or suffered from poor completion rates (13).
All documents will be stored securely and only accessible by staff and authorised personnel. The study will comply
with the Data Protection Act which requires data to be anonymised as soon as it is practical to do so and the NHS
Code of Confidentiality. The study staff will ensure that the participants’ anonymity is maintained. The CI maintains
responsibility for completion and submission of appropriate forms or data input. Standardised CRFs will be used. All
source documents must be maintained as required by the protocol, including patient CRFs, supporting medical
records, and consent documents.
Anonymised data may be shared with the researchers within the institution; every consideration will be discussed on
the steering committee and based on merit. Data will not be shared with external researchers. Members of the
University of Oxford or Oxford University Hospitals NHS Trust may be given access to information for monitoring and/or
audit of the study to ensure the compliance with the regulations.
The team will maintain a record of all research projects using data from the JAVLIN Registry. The record will contain
full title of the projects, summaries of its purpose, names of PI’s, sponsors, location of the research, data of which the
project was approved by the steering committee, brief summary of the dataset released and any relevant reference
numbers.Research programme
Male or female participants aged 18 or over, receiving hip or knee arthroplasty at the Nuffield Orthopaedic Centre, willing and able to give informed consent will be included in the study. To avoid overburdening the patients with the duplicate questionnaires, the JAVLIN database will (with the permission of patients) copy the routinely collected preoperative PROMs questionnaires. The following data will be collected on the data subjects: • Demographics (gender, year of birth, BMI) • Details of MRI and X ray findings • Stated indication for this arthroplasty • Q1 (first set of questionnaires) from the NHS PROMs audit • Oxford Knee scores Activity and Participation questionnaire at baseline • Patient Experience Questionnaire (EQ) • Musculoskeletal Patient Reported Outcome Measure (MPROM)
Research database title
Local JAVLIN Registry - Joint Arthroplasty Validated InformatioN Registry
Establishment organisation
University of Oxford
Establishment organisation address
Botnar Institute of Musculoskeletal Sciences
Nuffield Orthopaedic Centre
Windmill Road
OX3 7LD