Clinical trial NCT02012803: Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial
Official title: Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Achilles tendon rupture
treatment, elongation
operative treatment of achilles tendon rupture
conservative treatment of achilles tendon rupture
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months.

Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.


Eligibility criteria: Inclusion Criteria:

* 18-65 years, Clinical diagnosis of total achilles tendon rupture, ultrasonography controlled tendon ends reposition when ankle is in equinus/ plantar flexion.

Exclusion Criteria:

* earlier achilles tendon disorders, corticosteroid injections in achilles tendon, fluorokinolol-antibiotics in 2 years earlier, systemic corticosteroid medication, diabetes, peripheral arterial disease, more than 7 days old rupture, patient lives abroad or patient refused to participate.

Primary outcomes:
measure: Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.
timeFrame: 18 months
Secondary outcomes:
measure: Complications in treatment of achilles tendon rupture.
timeFrame: 18 months
measure: Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.
timeFrame: 18 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
References:
citation: Heikkinen J, Lantto I, Flinkkila T, Ohtonen P, Niinimaki J, Siira P, Laine V, Leppilahti J. Soleus Atrophy Is Common After the Nonsurgical Treatment of Acute Achilles Tendon Ruptures: A Randomized Clinical Trial Comparing Surgical and Nonsurgical Functional Treatments. Am J Sports Med. 2017 May;45(6):1395-1404. doi: 10.1177/0363546517694610. Epub 2017 Mar 10.
citation: Lantto I, Heikkinen J, Flinkkila T, Ohtonen P, Siira P, Laine V, Leppilahti J. A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures. Am J Sports Med. 2016 Sep;44(9):2406-14. doi: 10.1177/0363546516651060. Epub 2016 Jun 15.