The value of Autologous Tenocyte Implantation in patients with chronic Achilles tendinopathy: a double-blind randomised clinical trial

Phase 2

Completed

Conditions: Achillodynia
tendon overuse injury
10043237

Registration Number: NL-OMON38070

Lead Sponsor: Erasmus MC orthopaedic department

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

1. Pain on palpation 2-7 cm proximal from the tendon insertion (midportion)
2. Symptoms > 2 months
3. Age 18-55 years

Exclusion Criteria

- Clinical suspicion of insertional disorders , Achilles tendon rupture, plantar flexor tenosynovitis, sural nerve pathology, peroneal subluxation
- Condition of the Achilles tendon caused by medications such as quinolones and statins
- Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis.
- Antibiotics allergy (aminoglycoside group)
- A condition that prevents the patients from executing an active rehabilitation programme
- Patient has received an injection for this injury
- Patient has received surgical intervention for this injury
- Patient has already one site (left or right) included in this study
- Patient does not wish, for whatever reason, to undergo one of the two treatments
- Known pregnancy
- Nursing women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measurement: VISA-A score, a validated instrument to detect the<br /><br>severity of symptoms in patients with Achilles tendinopathy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As secondary outcome measurements subjective patient satisfaction and return to<br /><br>sports will be rated. For the evaluation of tendon repair, Ultrasonographic<br /><br>Tissue Characterization (UTC) will be performed. UTC was developed, that<br /><br>provides quantitative information on tendon fiber alignment and the related<br /><br>ultra-structural integrity of the tendon tissue through a non-invasive approach<br /><br>and is used in several clinical trials in humans. </p><br>