Recover L-PRP in Lateral Epicondylitis (REGP-11-00)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Biological: Leukocyte- and Platelet-Rich Plasma (L-PRP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed an independent ethics committee (IEC)-approved informed consent form (ICF). Male or female of ≥ 18 years of age Confirmed diagnosis of unilateral chronic LE Duration of chronic LE symptoms ≥ 3 months Failed at least one previous LE treatment (e.g. wait and see, physiotherapy, analgesics, NSAIDs, anti-inflammatory steroid injection and bracing, etc.). Exclusion Criteria: No active systemic inflammatory condition (e.g., rheumatoid arthritis) No active leukemia or metastatic malignant cells No current chemotherapy treatments No pregnancy No lactation No infected tendons, skin infection or skin disease in the area of the injection site. Participating in another drug or device study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Leukocyte- 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of interest |  | Evaluated at 3, 6, 12, 24 and 36 months | 
| Numeric Rating Scale (NRS) | Measure change in pain | Evaluated at 3, 6, 12, 24 and 36 months | 
| Disability of the arm, shoulder and hand (QuickDASH) questionnaire | Measure change in arm function | Evaluated at 3, 6, 12, 24 and 36 months | 
| European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L) | Measure change in quality of life | Evaluated at 3, 6, 12, 24 and 36 months | 
| Resource utilization | Cost of healthcare associated with chronic LE treatment | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lateral Epicondylitis, Leukocyte- and Platelet-Rich Plasma, Recover-L-PRP