Clinical trial NCT03525964: Individualized Treatment of Acute Achilles Tendon Rupture
Official title: Individualized Treatment for Acute Achilles Tendon Rupture Based on Barfod's Ultrasonographic Length Measure - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Individualized treatment
Functional outcome
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
First posted: 2018-05-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective
Primary purpose: TREATMENT

Brief summary: To asses the functional outcome after individualized treatment of acute achilles tendon rupture. The treatment is individualizes on the basis of ultrasonographic status of tendon overlap and Barfod's Ultrasonographic length measure. Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.

The study includes two control groups of non-operative and operative treatment.


Eligibility criteria: Inclusion Criteria:

* Appointment in the Outpatients Department within 4 days of injury.
* Total Achilles tendon rupture.
* Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
* The patient must be expected to be able to attend rehabilitation and post-examinations.
* The patient must be able to speak and understand Danish.
* The patient must be able to give informed consent.

Exclusion Criteria:

* Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
* Previous rupture of the Achilles tendon in any of the two legs.
* Treated with Fluoroquinolones or corticosteroids within the last 6 months.
* In medical treatment of diabetes.
* Suffers from rheumatic disease.
* Other conditions prior to the injury resulting in reduced function of any of the two legs.
* Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
* Inability to lie in prone position on the operating table.
* Terminal illness or severe medical illness: ASA (American Society of Anesthesiologists) score higher than or equal to 3.

Primary outcomes:
measure: Heel-rise work test
timeFrame: Evaluation method after 12 months of started treatment
Secondary outcomes:
measure: Barfod's ultrasonographic length measure
timeFrame: Evaluation method after 6 and 12 months of started treatment
measure: Indirectly, clinical Achilles tendon length estimate
timeFrame: Evaluation method after 6 and 12 months of started treatment
measure: Complications
timeFrame: Evaluation method after 12 months of started treatment
measure: Achilles tendon Total Rupture Score (ATRS)
timeFrame: Evaluation method after 6 and 12 months of started treatment
measure: Heel-rise Work test
timeFrame: Evaluation method after 6 months of started treatment
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
city: Kolding
country: Denmark
facility: Hospital Lillte Belt, Kolding
city: Køge
country: Denmark
facility: Zealand University Hospital, Køge
city: Viborg
country: Denmark
facility: Jutland Central Regional Hospital
Study officials:
affiliation: Central Jutland Regional Hospital
name: Marianne T Vestermark, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barfod KW, Riecke AF, Boesen A, Hansen P, Maier JF, Dossing S, Troelsen A. Validation of a novel ultrasound measurement of achilles tendon length. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3398-406. doi: 10.1007/s00167-014-3175-2. Epub 2014 Jul 20.
citation: Hansen MS, Vestermark MT, Holmich P, Kristensen MT, Barfod KW. Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial. Trials. 2020 May 12;21(1):399. doi: 10.1186/s13063-020-04332-z.