Prospective randomized study of the effect of autologous concentrated thrombocytes versus corticosteroidinjection 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 any
given time.
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 that
micro- and macroscopic lesions in the common origin of wrist- and
fingerextensors (CEO) occur as a result of mechanical overload.
Histological specimens from chronic cases confirm that it's not an acute
inflammatory condition but rather a a failure of the normal tendon repair
mechanism associated with an angiofibroblastic degeneration with deposition of
glycosaminoglycane, calcification an dchanges in cellmorphology. Abnormal
fibroblast differentiation has an important role in the pathogenesis of
tendinosis.

Injections of corticosteroids have been proven to decrease the pain temporarily
and is the gold standard in the therapy of lateral epicondylitis.
However, the 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-steroideal anti-inflammatory medication, corticosteroidinjections,
botulism toxin injection, acupuncture etc. Howerver, few of the therapies rest
on scientific evidence and none have been proven more effective than others.
An experimental treatment is the local injection of of autologous platelet
concentrate obtained from a small volume of
autologous blood into the CEO.
This concept expands on the work by Edwards et al (2003) where 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 tendon lesions.
The PRP has an 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 (GF) that are essential for the repair of
tissue; Platelet Derived Growth Factor, Transforming GF's, Insulin like GF,
Vascular Endothelial GF, Epidermal GF en Fibroblast GF. These GF can activate
immature fibroblasts, as well as stimulate cellproliferation and vascular
formation.
By activating the platelets several GF are released, which enhance the repair
of the CEO, therefore decreasing pain.

The objective of this study is to prove that a single injection of PRP in the
CEO decreases 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 is designed as a prospective reandomized study, where patients
receive a single injection in the CEO. Patients will be randomly designed into
one of the two treatmentgroups. The patient in the studygroup will receive an
injection of buffered autologous platelet concentrate and the controlegroup of
of lidocaine and corticosteroids in identical syringes.
The studywill be conducted over a period of 1 year an d contain a maximum 115
investgational with an equivalent number of control cases. All enrolledpatients
will meet the inclusion criteria.
The study will continue until all study participants reach their 52-week
follow-up assessment.

As with any procedure involving injection, therare risks involved with
pbufferded 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 evenets may be fatal. Thes possible
adverse events are not unique to the RecoverTM kit and as stated above may
occur with any procedure involving an injection.

Potential risk associated with device:
Patient participating in the study may be sunject to increased risk and/or
adverse events including, but not limited to:
- pain
- deep venous thrombosis
- scar tissue formation
- reaction to Lidocaine, which could involve allergic reaction, local toxicity
and potentially intravascular injection.
- thrombotic complications

Minimization of risk:
To minmaize risk, the investigational plan has defined a patientpopulation
that limts exposure of the device to patients conforming to the proposed
indications and in/exclusions.