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

January 8, 2018 updated by: Zimmer Biomet

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events of interest
Time Frame: Evaluated at 3, 6, 12, 24 and 36 months
Evaluated at 3, 6, 12, 24 and 36 months
Numeric Rating Scale (NRS)
Time Frame: Evaluated at 3, 6, 12, 24 and 36 months
Measure change in pain
Evaluated at 3, 6, 12, 24 and 36 months
Disability of the arm, shoulder and hand (QuickDASH) questionnaire
Time Frame: Evaluated at 3, 6, 12, 24 and 36 months
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)
Time Frame: Evaluated at 3, 6, 12, 24 and 36 months
Measure change in quality of life
Evaluated at 3, 6, 12, 24 and 36 months
Resource utilization
Time Frame: Evaluated at 3, 6, 12, 24 and 36 months
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
Time Frame: Evaluated at 3, 6, 12, 24 and 36 months
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
Time Frame: Evaluated at 3, 6, 12, 24 and 36 months
Evaluated at 3, 6, 12, 24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zimmer Biomet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adam Watts, MD, Wrightington Hospital, Wigan, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BBIO.CR.LPRP.PMD.001.15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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