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

Lateral Epicondylitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02588040
• Other study ID #: BBIO.CR.LPRP.PMD.001.15
• Status: Terminated
• Phase: N/A
• First received: October 26, 2015
• Last updated: January 8, 2018
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Wrightington Hospital	Appley Bridge

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events of interest		Evaluated at 3, 6, 12, 24 and 36 months
Secondary	Numeric Rating Scale (NRS)	Measure change in pain	Evaluated at 3, 6, 12, 24 and 36 months
Secondary	Disability of the arm, shoulder and hand (QuickDASH) questionnaire	Measure change in arm function	Evaluated at 3, 6, 12, 24 and 36 months
Secondary	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
Secondary	Resource utilization	Cost of healthcare associated with chronic LE treatment	Evaluated at 3, 6, 12, 24 and 36 months
Secondary	Number of injections of Recover L-PRP per patient in patients reaching symptom relief		Evaluated at 3, 6, 12, 24 and 36 months
Secondary	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