Clinical trial NCT02588040: Recover L-PRP in Lateral Epicondylitis (REGP-11-00)
Official 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lateral Epicondylitis
Keywords: Chronic Lateral Epicondylitis
Leukocyte- and Platelet-Rich Plasma
Recover-L-PRP
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with chronic lateral epicondylitis (duration of symptoms ≥ 3 months)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events of interest
timeFrame: Evaluated at 3, 6, 12, 24 and 36 months
measure: Numeric Rating Scale (NRS)
timeFrame: Evaluated at 3, 6, 12, 24 and 36 months
measure: Disability of the arm, shoulder and hand (QuickDASH) questionnaire
timeFrame: Evaluated at 3, 6, 12, 24 and 36 months
measure: European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)
timeFrame: Evaluated at 3, 6, 12, 24 and 36 months
measure: Resource utilization
timeFrame: Evaluated at 3, 6, 12, 24 and 36 months
measure: Number of injections of Recover L-PRP per patient in patients reaching symptom relief
timeFrame: Evaluated at 3, 6, 12, 24 and 36 months
measure: Number of patients who have no recurrence of chronic LE within 36 months of the initial L-PRP injection
timeFrame: Evaluated at 3, 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Appley Bridge
country: United Kingdom
facility: Wrightington Hospital
Study officials:
affiliation: Wrightington Hospital, Wigan, United Kingdom
name: Adam Watts, MD
role: PRINCIPAL_INVESTIGATOR
References: