Prospective randomized study of the effect of autologous concentrated thrombocytes versus corticosteroid injections in lateral epicondylitis.

Tenniselbow, also known as lateral epicondylitis is the most common disorder of
the elbow and is present in approximately 1.5% of the population at some time.
The incidence is 6 per 1000 and the prevalence 7 per 1000 patients per year.
More than half of the patients with lateral epicondylitis do not visit the
general practitioner. 3-6 % of the patients are send to the orthopedic surgeon.
Manual workers and racket sports athletes are at high risk.
The condition typically affects patients between 35 and 50 years old.
The exact cause of lateral epicondylitis is unknown. It is assumed that micro-
and
macroscopic lesions in the common origo of wrist- and fingerextensors (COE) are
involved. The lesions are usually caused by overuse of these muscles.
Histology specimens from chronic cases confirm that it is not an acute
inflammatory condition, but rather a failure of the normal tendon repair
mechanism associated with angiofibroblastic degeneration with deposition of
glycosaminoglycane, calcification and changes in cellmorphology. Abnormal
fibroblastdifferentiation has an important role in thee pathogenesis of
tendinosis.

Injections of corticosteroids have been proven to decrease the pain temporarily
and is the golden standard in therapy of lateral epicondylitis.
However, te condition can persist for a long period of time and/or with such
intense pain that alternative treatment is indicated.
Numerous methods have been advocated for treating tenniselbow. These include
rest, activity restriction, bracing, physical therapy, extracorporal shockwave
therapy, non-steroidal anti-inflammatory medication, corticosteroidinjections,
botulism toxininjections, acupuncture etc. However, few of the therapies rest
on scientific evidence and none has been proven more effective than the others.
A new therapy is the local injection of autologous platelet concentrate
obtained from a small volume of autologous blood, into the COE.
This concept expands on the work by Edwards et al [2003] where whole blood was
injected into the area, and directly addresses the underlying etiology.
In previous studies it has also been proven that injection of 'Platelet Rich
Plasma' (PRP) in patients with plantary fasciitis enhances repair.
The same has been proven in rats with Achilles tendonlaesions.
The PRP has a 5-8 times higher concentration of platelets compared to normal
blood. Platelets play an important role in the repair of tissuedamage.
They contain several growthfactors that are essential for the repair of tissue;
Platelet Derived Growth Factor, Transforming GF-ß, Insulin like GF, Vascular
Endothelial GF, Epidermal GF en Fibroblast GF. These growthfactors can activate
immature fibroblasts, as well as stimulate celproliferation and vascular
formation.
By activating the platelets several growthfactors are released, which enhance
the repair of the COE, therefore decreasing the pain.

The objective of this study is to prove that a single injection of PRP in the
COE decreases the pain and duration of the condition in patients with chronic
lateral epicondylitis compared to injection with lidocaine and corticosteroids.
The specific objective is to give patients with chronic lateral epicondylitis
an alternative before opting for surgical treatment.

The study design is a prospective randomized study, where patients receive a
single injection in the COE.
Patients will be randomly assigned into one of two treatment arms. The patients
in the studygroup will receive an injection of buffered autologous platelet
concentrate and the patients in the controlgroup will receive an injection of
lidocaine and corticosteroids in identical syringes.
The study will be conducted over a period of 6 months and contain a maximum of
115 investigational cases with an equivalent number of control cases. All
enrolled patients will meet the inclusion criteria. The study will continue
until all study participants reach their 24-week follow-up assessment.

As with any procedure involving an injection, there are risks involved with the
injection of buffered autologous platelet concentrate for treatment of lateral
epicondylitis. Potential adverse events include, but are not limited to:
bleeding, infection, nerve/nervous system damage, no relief of symptoms, and
worsening of symptoms. Rarely, some adverse events may be fatal. These possible
adverse events are not unique to the RecoverTM Kit and as stated above, may
occur with any procedure involving an injection.

Potential Risks Associated with Device
Patients participating in the study may be subject to increased risks and/or
adverse invents including, but not limited to:
• Pain
• Deep venous thrombosis
• Scar tissue formation
• Reaction to Bupivacaine/Epinephrine, which could involve allergic reaction,
local toxicity, and potentially intravascular injection
• Thrombotic complications

Minimization of Risk
To minimize risk, the investigational plan has defined a patient population
that limits exposure of the device to patients conforming to the proposed
indications and inclusions/exclusions.