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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38070
Enrollment
90
Registered
2010-08-02
Start date
2011-04-29
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achillodynia tendon overuse injury

Interventions

Sponsors

Erasmus MC orthopaedic department
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Secondary

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

Primary

MeasureTime frame
Primary outcome measurement: VISA-A score, a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)