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

Zimmer Biomet

Status: Terminated

Conditions: Lateral Epicondylitis

Treatments: Biological: Leukocyte- and Platelet-Rich Plasma (L-PRP)

Study type: Observational

Funder types: Industry

Identifiers

NCT02588040

BBIO.CR.LPRP.PMD.001.15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.