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

NCT ID: NCT02588040

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-09-30

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.

Conditions

Lateral Epicondylitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Watts, MD

Role: PRINCIPAL_INVESTIGATOR

Wrightington Hospital, Wigan, United Kingdom

Locations

Wrightington Hospital

Appley Bridge, , United Kingdom

Countries

United Kingdom

Other Identifiers

BBIO.CR.LPRP.PMD.001.15

Identifier Type: -

Identifier Source: org_study_id