Lateral Epicondylitis
Conditions
Keywords
Chronic Lateral Epicondylitis, Leukocyte- and Platelet-Rich Plasma, Recover-L-PRP
Brief summary
The objective of the study is to further characterize the performance of L-PRP prepared using the Biomet Recover Kit in the treatment of chronic LE. The study will explore the potential impact of patient demographics and baseline characteristics on treatment outcome. Furthermore it will track and document treatment effects, time course, and untoward effects following treatment of chronic LE with L-PRP from the Recover device. In addition, the utilization of healthcare resources and associated costs will be investigated in treated patients.
Detailed description
Clinical trials have been conducted to determine the efficacy and safety of Leukocyte- and Platelet-Rich Plasma (L-PRP) prepared with Biomet Recover L-PRP Mini Platelet Separation Kit for the treatment of tendinosis in a controlled setting. This study will allow for the capture and evaluation of real-world clinical data on a chronic LE patient population. The advantage of a post-market data collection is that it provides a way to examine clinical and patient reported outcomes along with the associated costs of chronic LE treatment in a diverse, clinically-relevant population. Although several registries exist which capture the outcomes following tendon/ligament reconstruction surgery, there are no known registries that capture outcomes following non-surgical treatment of chronic LE with Recover L-PRP. This study will fill that gap by allowing for an efficient data collection platform in a larger heterogeneous population of patients suffering from chronic LE and will document and more closely examine the treatment effects of Recover L-PRP.
Interventions
BIOLOGICALLeukocyte- and Platelet-Rich Plasma (L-PRP)
The Recover L-PRP Mini Platelet Separation Kit aids in the separation of the patient's own blood components by density through the use of a Biomet Biologics centrifuge.
Sponsors
Zimmer Biomet
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed an independent ethics committee (IEC)-approved informed consent form (ICF). 2. Male or female of ≥ 18 years of age 3. Confirmed diagnosis of unilateral chronic LE 4. Duration of chronic LE symptoms ≥ 3 months 5. Failed at least one previous LE treatment (e.g. wait and see, physiotherapy, analgesics, NSAIDs, anti-inflammatory steroid injection and bracing, etc.).
Exclusion criteria
6. No active systemic inflammatory condition (e.g., rheumatoid arthritis) 7. No active leukemia or metastatic malignant cells 8. No current chemotherapy treatments 9. No pregnancy 10. No lactation 11. No infected tendons, skin infection or skin disease in the area of the injection site. 12. Participating in another drug or device study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study will be to measure number of patients who achieve resolution of chronic LE symptoms at 6 months following initial injection with Recover L-PRP. | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | Evaluated at 3, 6, 12, 24 and 36 months | Measure change in pain |
| Disability of the arm, shoulder and hand (QuickDASH) questionnaire | Evaluated at 3, 6, 12, 24 and 36 months | Measure change in arm function |
| European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L) | Evaluated at 3, 6, 12, 24 and 36 months | Measure change in quality of life |
| Adverse events of interest | Evaluated at 3, 6, 12, 24 and 36 months | — |
| Number of injections of Recover L-PRP per patient in patients reaching symptom relief | Evaluated at 3, 6, 12, 24 and 36 months | — |
| Number of patients who have no recurrence of chronic LE within 36 months of the initial L-PRP injection | Evaluated at 3, 6, 12, 24 and 36 months | — |
| Resource utilization | Evaluated at 3, 6, 12, 24 and 36 months | Cost of healthcare associated with chronic LE treatment |
Countries
United Kingdom
Outcome results
None listed