This study is designed to compare the treatment of 2 groups: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measurement: VISA-A score, a validated instrument to detect the
severity of symptoms in patients with Achilles tendinopathy.
Secondary outcome
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.
Background summary
Overuse injury of the Achilles tendon is a common entity. When the exact origin
of tendon pain is unclear, the term tendinopathy is preferred. Most accepted
treatment at this moment is an eccentric exercise programme, according to the
Dutch guidelines. However, a recent systematic review on the effectiveness of
eccentric exercises to treat lower extremity tendinoses concluded that it is
unclear whether eccentric exercises are more effective than other forms of
treatment. Recent studies described new treatment strategies in tendinopathies,
such as the use autologous Tenocyte Implantation (ATI). This treatment option
can participate actively in tissue repair processes on cell level.
The only published clinical pilot study in tendon research reported 60%
improvement in all scores after 6 months follow-up.
Study objective
This study is designed to compare the treatment of 2 groups: autologous
tenocytes injection in combination with exercises versus saline injection in
combination with exercises.
Study design
The study will be a double-blind randomised single-centre clinical trial
comparing 2 treatment groups. The researcher, the sports medicine physician and
the patients will be blinded to the received therapy.
Intervention
All patients will perform a heavy load eccentric exercise programme, consisting
of 180 repetitions daily. The patients will be randomized into 2 treatment
groups: ultrasound guided intratendinous saline injection with eccentric
exercises and ultrasound guided intratendinous ATI (autologous tenocyte
implantation) injection with eccentric exercises.
Study burden and risks
The intratendinous injections may be painful and a hematoma can arise. In
previous (animal) studies on the effect of autologous tenocyte implantation on
tendon disorders at other locations, it was reported that no tendon ruptures
occured. However, we are not sure whether these results could be extrapolated
to the Achilles tendon. A pilot study in patients with tennis elbow did not
show this technique to be unsafe. The eccentric exercises are frequently
painful and it requires discipline. Moreover, there are 3 follow-up moments and
1 follow-up by phone for the patients after injection (with the duration of 30
minutes per appointment).
Dr Molewaterplein 50
Rotterdam 3015GE
NL
Dr Molewaterplein 50
Rotterdam 3015GE
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021869-73-NL |
| CCMO | NL33178.000.10 |