Post Market Data Collection: L-PRP for Chronic Lateral Epicondylitis
Research type
Research Study
Full title
Post-Market Data Collection for Chronic Lateral Epicondylitis Patients Treated with Leukocyte- and Platelet-Rich Plasma (L-PRP) Prepared With the Recover Mini Platelet Separation Kit
IRAS ID
178378
Contact name
Cahit Akbas
Contact email
Sponsor organisation
Zimmer Biomet Biologics
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
This single-arm, multicenter, observational study will include up to 100 patients recruited from up to 8 centres from UK and Europe. Patients suffering from unilateral chronic tennis elbow (Lateral Epicondylitis), who are treated with Leukocyte-, and Platelet-Rich Plasma (L-PRP) from Recover kit may be enrolled in this data collection protocol. All subjects will be asked to provide informed consent before the collection of any patient specific information. L-PRP treatment is a part of standard care and will be applied independently from this data collection in accordance with its labeled indication. Following the initial injection with L-PRP, the patients will be followed at 3, 6, 12, 24, and 36 months. Each subject may receive up to 3 injections of L-PRP prepared using the Recover Kit if deemed beneficial by the treating physician. Follow-ups will remain time indexed to the initial injection procedure regardless of additional injections. At each follow-up, the following information may be collected:
• EQ-5D-3L Quality of Life (QoL) survey
• Numeric Rating Scale for Pain (NRS)
• Disabilities of the Arm, Shoulder and Hand Score (Quick DASH)
• Healthcare resource utilization diary
Adverse events of interest associated with the L-PRP injection(s) will be recorded throughout the study.
The patients will be followed in the study until one of the following:
• Completion of scheduled clinical evaluations to 36 months after the initial injection procedure (note: subjects who undergo subsequent injection(s) with L-PRP will remain time indexed to the initial injection), or
• Invasive treatment other than injection of L-PRP prepared with the Recover kit (e.g., steroid injection, surgery, etc.).
• Death, lost to follow-up, or study termination.REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0919
Date of REC Opinion
5 Jun 2015
REC opinion
Further Information Favourable Opinion