Lateral EpicondylitisNCT02588040
Recover L-PRP in Lateral Epicondylitis (REGP-11-00)
An observational study of Lateral Epicondylitis, run by Zimmer Biomet at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Leukocyte- and Platelet-Rich Plasma (L-PRP)
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Sep 2017
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed with chronic lateral epicondylitis (duration of symptoms ≥ 3 months)
Who may be able to join
- Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
- Male or female of ≥ 18 years of age
- Confirmed diagnosis of unilateral chronic LE
- Duration of chronic LE symptoms ≥ 3 months
- Failed at least one previous LE treatment (e.g. wait and see, physiotherapy, analgesics, NSAIDs, anti-inflammatory steroid injection and bracing, etc.).
Who cannot join
- No active systemic inflammatory condition (e.g., rheumatoid arthritis)
- No active leukemia or metastatic malignant cells
- No current chemotherapy treatments
- No pregnancy
- No lactation
- No infected tendons, skin infection or skin disease in the area of the injection site.
- Participating in another drug or device study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Leukocyte- and Platelet-Rich Plasma (L-PRP)
- Keywords
- Chronic Lateral Epicondylitis, Leukocyte- and Platelet-Rich Plasma, Recover-L-PRP
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte- and Platelet-Rich Plasma (L-PRP)Biological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
Adverse events of interest
Measured: Evaluated at 3, 6, 12, 24 and 36 months
Numeric Rating Scale (NRS)
Measure change in pain
Measured: Evaluated at 3, 6, 12, 24 and 36 months
Disability of the arm, shoulder and hand (QuickDASH) questionnaire
Measure change in arm function
Measured: 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
Measured: Evaluated at 3, 6, 12, 24 and 36 months
Resource utilization
Cost of healthcare associated with chronic LE treatment
Measured: Evaluated at 3, 6, 12, 24 and 36 months
Number of injections of Recover L-PRP per patient in patients reaching symptom relief
Measured: 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
Measured: Evaluated at 3, 6, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startMay 2016
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Not enough sites available to complete enrollment in a timely manner
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Watts, MD, Principal investigator, Wrightington Hospital, Wigan, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588040
- Sponsor's protocol ID
- BBIO.CR.LPRP.PMD.001.15
- Status last verified
- Jan 2018
- First submitted
- 26 Oct 2015
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02588040
- Acronym / sponsor ID
- BBIO.CR.LPRP.PMD.001.15
- Conditions
- Lateral Epicondylitis
- Keywords
- Chronic Lateral Epicondylitis, Leukocyte- and Platelet-Rich Plasma, Recover-L-PRP
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough sites available to complete enrollment in a timely manner
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with chronic lateral epicondylitis (duration of symptoms ≥ 3 months)
Key inclusion criteria (5 listed)
- Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
- Male or female of ≥ 18 years of age
- Confirmed diagnosis of unilateral chronic LE
- Duration of chronic LE symptoms ≥ 3 months
- Failed at least one previous LE treatment (e.g. wait and see, physiotherapy, analgesics, NSAIDs, anti-inflammatory steroid injection and bracing, etc.).
Key exclusion criteria (7 listed)
- No active systemic inflammatory condition (e.g., rheumatoid arthritis)
- No active leukemia or metastatic malignant cells
- No current chemotherapy treatments
- No pregnancy
- No lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | – |
Primary outcome
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
7 secondary outcomes
Adverse events of interest
Time frame: Evaluated at 3, 6, 12, 24 and 36 months
Numeric Rating Scale (NRS)
Time frame: 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
European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)
Time frame: Evaluated at 3, 6, 12, 24 and 36 months
Resource utilization
Time frame: 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
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
Results and safety
The study was stopped early (reason given: Not enough sites available to complete enrollment in a timely manner). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Lateral Epicondylitis
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Watts, MD principal investigator
Wrightington Hospital, Wigan, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Epicondylitis, run by Zimmer Biomet at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough sites available to complete enrollment in a timely manner). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.