Comparision of two treatments, MR2 versus GPS III®in patients with rotulian tendinopathy

Phase 1

• Conditions: Patients with Rotulian Tendinopathy; MedDRA version: 20.0Level: HLGTClassification code 10043237Term: Tendon, ligament and cartilage disordersSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-002129-39-ES
• Lead Sponsor: XCELL Medical Solutions

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-10
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patient that have willingly signed and have to be able to sign the informed
consent for the participation in the trial. 2. Patients aged between 18 and 70 years, in case of woman of fertile age, the use of a contraceptive method.
3. Outpatient before the injury, without help for walk or need to assistance of other
person. 4. Patients Diagnosed with unilateral lesion at the inferior pole of the patella,
with echographic images of anteroposterior thickening, focal area of hypoechoic
changes and discontinuity of tendon fibers. 5. Persistence of the symptoms after at
least 3 months of conservative treatment. 6. Patients for whom non-surgical
treatment has been decided. 7. Patient be able (in investigator´s opinion) to meet all
the study requirements. 8. Patients that practice sports usually, whether they are
elite athletes or amateurs. 9. Patients willing to attend the site for scheduled visits in
the 24-week of follow-up.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with lesions in both rotulian tendons
2. Severe pre-injury of tendon or ankle or deformity in any of the lower limbs.
3. Previous infiltration or previous
surgery on the knee.
4. Medical History of diabetes mellitus.
5. Patients with known plasma abnormalities or haematological disorder:
A. Platelet abnormality (<150,000
plat / mm3).
B. Hematologic abnormality.
C. Hemoglobin in blood <11g / dL or
hematocrit <34%
6. Current use of systemic cortisone or treatment with anticoagulants (ie, a prophylactic dose for the prevention of thrombosis would not
be an exclusion criteria)
7. Evidence of gangrene of the lower extremities / ulcers or
peripheral vascular disorder.
8. History of liver failure or renal failure or dialysis
9. Female patients who are pregnant or with the intention of becoming pregnant
10. Patients that currently are receiving radiotherapy or chemotherapy or has received it
in the last 3 months.
11. Patients with an inadequate venous access for blood
collection.
12. Any other significant disease or disorder that, in the opinion of the investigator, could put participants at risk due to participation in the study, or may influence in the results of the study, or the ability of patients to participate in the study .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified