The Value of Platelet-Rich Plasma in Chronic Midportion Achilles Tendinopathy: a Double-Blind Randomized Clinical Trial
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Achilles Tendinopathy
Intervention: PRP Injection without eccentric exercises (Biological); PRP Injection with eccentric exercises (Biological); Placebo Injection with eccentric exercises (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
RJ De Vos, MD, Principal Investigator, Affiliation: Erasmus Medical Center, Rotterdam
Overall contact:
RJ De Vos, MD, Phone: +31-10-7040704
Summary
The study will be a double-blind randomized single-centre clinical trial comparing 3
treatment groups in patients with chronic midportion Achilles tendinopathy:
1. Ultrasound guided intratendinous "placebo injection" with eccentric exercises
2. Ultrasound guided intratendinous PRP injection with eccentric exercises
3. Ultrasound guided intratendinous PRP injection without eccentric exercises
Clinical Details
Official title: The Value of Platelet-Rich Plasma in Chronic Midportion Achilles Tendinopathy: a Double-Blind Randomized Clinical Trial
Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: VISA-A Score
Secondary outcome: Ultrasonographic Tissue CharacterizationComplications
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion criteria
- Age 18-70 years
- Participation in sports activities for at least one hour a week before the onset of
symptoms
- Painful Achilles tendon during or after sports for more than 2 months
- Pain on palpation in the tendon, 2-7 cm proximal to its calcaneal insertion Exclusion
criteria
- Insertional Achilles tendinopathy
- Previous participation in a heavy load eccentric exercise program or treatment with
autologous blood for this injury.
- Inability to perform a heavy load eccentric exercise program
- Participation in other concomitant treatment programs
- Regular use of prescribed drugs with a putative effect on symptoms and tendon healing
(quinolone antibiotics, NSAID)
- Presence of a pregnancy
- Previous Achilles tendon rupture
- Suspicion of a systemic disease
Locations and Contacts
RJ De Vos, MD, Phone: +31-10-7040704
Erasmus Medical Center, Rotterdam, Netherlands; Recruiting
R J De Vos, MD, Phone: +31-10-7040704
Additional Information
Starting date: August 2008
Ending date: October 2012
Last updated: September 26, 2008
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