Clinical trial NCT02309307: Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
Official title: A Prospective, Open Label, Single Arm, Multi-center Study to Assess the Safety and Performance of a Soft Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Ruptured Tendon Injuries
Tendinopathy
Keywords: safety and performance
Lead sponsor: Collplant
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The VergenixTM STR device is intended for the repair of non ruptured tendon injuries (Tendinopathy).

Detailed description: The VergenixTM STR device is an advanced Soft tissue repair device, made of lyophilized Type I rhCollagen and Calcium Chloride that will be mixed with autologous PRP prior to injection for the repair of non ruptured tendon injuries (Tendinopathy). Three (3) ml of the mixed solution will be injected into the common extensor tendon.

Eligibility criteria: Inclusion Criteria:

1. Man or woman aged 18 - 80 years old.
2. Clinical diagnosis of lateral epicondylitis based on site of pain, pain

   elicited with active extension of the wrist in pronation and elbow

   extension.
3. Documented ultrasonography diagnosis of common extensor

   tendinosis and possible tear based on abnormal echotexture (tendon

   thickening, anechoic areas, areas of hypoechogencicity, loss of

   fibrillar pattern).
4. Chronic symptoms (equal or greater than 3 months).
5. PRTEE questionnaire score of at least 50 out of 100.
6. For child-bearing potential females, documentation of birth

   control.
7. Signing informed consent form. -

Exclusion Criteria:

1. Acute symptom onset (less than 3 months).
2. History of acute elbow trauma.
3. History of Rheumatoid Arthritis.
4. History of Inflammatory disease
5. History of Fibromyalgia
6. The patient has active malignant disease of any kind. A patient who

   has had a malignant disease in the past, was treated and is currently

   disease-free for at least 5 years, may be considered for study entry.
7. The patient is treated with anti-coagulant medication
8. The patient previously underwent a surgery for lateral

   epicondylitis.
9. The patient previously received local injections, including steroids

   within the last 30 days
10. Signs of other causes for lateral elbow pain (posterior interosseous

    nerve entrapment, osteochondral lesion).
11. Wounds around the elbow
12. Likely problems, in the judgment of the investigator, with maintaining follow-up.
13. Clinically significant abnormalities in hematology and blood

    chemistry lab tests at screening that in the opinion of the

    investigator might interfere with the patient's safety or participation

    in the study.
14. Known as positive HIV, hepatitis B, or hepatitis C.
15. Known history of a significant medical disorder, which in the

    investigator's judgment contraindicates the patient's participation.
16. Known hypersensitivity and/or allergy to collagen.
17. Drug or alcohol abuse (by history).
18. Pregnancy of child-bearing potential females.
19. Participation in another study within 30 days prior to screening

visit.

-

Primary outcomes:
measure: Changes in pain as a continuous outcome measure using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
timeFrame: Up to 194 days
measure: Functional Disability using the PRTEE questionnaire.
timeFrame: Up to 194 days
measure: Tendon thickness (i.e tendon healing/improvement) and Doppler activity using US at 3M.
timeFrame: Up to 194 days
measure: Health related Quality of life parameters questionnaire.
timeFrame: Up to 194 days
measure: Pain free/maximum grip strength (Dynamometer)
timeFrame: Up to 194 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah MC
city: Kfar Saba
country: Israel
facility: Meir MC
city: Zrifin
country: Israel
facility: Assaf Harofeh MC
Study officials:
References: