Research and Clinical Trials - Case Studies
Without patient participation clinical trials could not take place. Many patients who take part in trials benefit from obtaining successful new treatments before they are available and experience improved quality of life.
To give you an idea of what it is like to take part in a trial, some of our patients who have participated, share their stories in the videos below.
Press the play button to start the video. Please make sure you have speakers connected and they are switched on to hear the audio.
Robert has taken part in a clinical trial which aims to reduce the symptoms of Psoriatic Arthritis. Here is his story.
Bryan has taken part in a clinical trial which aims to reduce the symptoms of Tinnitus. Here is his story.
S-33 study – National data opt out
Clinical and Radiographic outcomes of reverse shoulder arthroplasty performed with 36- mm CoCrMo vs 40-mm cross-linked UHMWPE glenospheres at minimum 2-years follow up
This research study is being funded and sponsored by Limacorporate S.p.A. (the company who make the shoulder device).
The study has been approved by the East of England – Cambridge Central Research Ethics Committee, the Health Research Authority and is supported by the Confidentiality Advisory Group where necessary, to allow researchers to access patient information with and on behalf of the direct care team.
Full study details can be found on the national clinical trials database using the study identifier NCT 05339815.
The Chief Investigator for this study is Professor Ian Trail.
We are reviewing patients who were treated with the LIMA SMR Reverse Shoulder System. The information collected will be used to assess the safety and effectiveness of the SMR Reverse HP Shoulder System device, up to 24 months following surgery. There will be 140 -160 patients recruited for the study from Wrightington Hospital.
- Whose data will be collected?
We need to try to collect outcome information and x-rays from as many patients as possible to avoid any bias, that means we don’t pick and choose which patients are included.
Only patients who were implanted with this type of shoulder device between January 2013 and January 2020 will have their data reviewed.
- What will we collect?
The data we plan to collect will include demographic information, relevant medical history, scores from Patient Reported Outcome Measures (PROM questionnaires) and Clinical examinations. Information on medication and any side effects from the surgery or implant will be noted. Copies of scans and x-rays taken will also be collected.
- How will we collect the data?
Patients who have the specific shoulder replacement parts (noted in the full study title above) will be identified by the direct care team. Patient NHS numbers will be used to check if anyone has chosen to opt out of their data being used in research.
- Patients who do not have the required 2 year outcome data and x-rays will be contacted by the direct care team and sent information about the study. Patients who agree to participate in the study, will be offered a clinical appointment with a member of the upper limb surgical team. At this visit, patients will be asked to sign a consent form and will undertake required imaging and complete questionnaires as required.
- Patients who already have all the required x-rays and outcome data available will not be contacted directly, unless they opted out of research nationally. Wrightington, Wigan and Leigh is a research active Trust and any patient completing outcome questionnaires about their shoulder since February 2016, will have consented for such data to be stored in the upper limb research unit and to be used for future studies of this type. Researchers from the upper limb unit will work with the direct care team to find and review the available data.
- The same information will also be accessed about patients who had this shoulder replacement for 2 years but are no longer living.
- How will the information be used?
Each set of information collected about a patient recruited into the study, will be coded with a unique study identifier. This allows researchers at Wrightington Hospital and from the sponsor to know which information came from a particular patient- without identifying that patient.
The coded data and x-rays will be sent to the Sponsor and their team who are doing the final review. None of the information provided to the manufacturer will identify any patient from whom data is collected.
Patients who are eligible for the study will be contacted by the direct care team if further visits are required.
If you think this study might affect you and you want to know if your data is being used, you can contact the upper limb research team on 01257 488212. Please provide your NHS number so we can check if you are eligible.
If you do not wish to participate in this study and want to ensure your data is not used, you may contact us directly about this study or use the national data opt out service at (https://digital.nhs.uk/services/national-data-opt-out) to opt out of research completely.