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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Biological: Leukocyte- and Platelet-Rich Plasma (L-PRP)

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United Kingdom
  • Appley Bridge, United Kingdom
    • Wrightington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with chronic lateral epicondylitis (duration of symptoms ≥ 3 months)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Adam Watts, MD, Wrightington Hospital, Wigan, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Lateral Epicondylitis; Leukocyte- and Platelet-Rich Plasma; Recover-L-PRP
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: BBIO.CR.LPRP.PMD.001.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED