Clinical trial NCT03543943: Achilles Tendon Elongation and Gait Pattern After Rupture.
Official title: Achilles Tendon Elongation and Gait Pattern After Rupture: A Three Armed Randomized Controlled Trial Comparing an Individualized Treatment Algorithm vs. Operative or Non-operative Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2018-06-01
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 objective of this study is to determine if Achilles tendon elongation and gait pattern differ between patients treated using an individualized treatment algorithm and patients treated as usual (two control groups; patients treated operatively and non-operatively).

The individualized treatment algorithm is based on ultrasonographic status of tendon overlap and Copenhagen Achilles Length Measure (1). 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.


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 postexamination.
* 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: American Society of Anaesthesiologists physical status classification score higher than or equal to 3.

Primary outcomes:
measure: Three-Dimensional Gait Analysis: Ankle peak power during push-off.
timeFrame: 12 months after started treatment.
Secondary outcomes:
measure: Copenhagen Achilles Length Measure
timeFrame: 6 and 12 months after started treatment.
measure: Three-Dimensional Gait Analysis: Ankle peak power during push-off
timeFrame: 6 months after started treatment.
measure: Three-Dimensional Gait Analysis: Maximal dorsiflexion in the stance phase.
timeFrame: 6 and 12 months after started treatment.
measure: Three-Dimensional Gait Analysis: stiffness of the plantar flexor musculo-tendinous complex during dorsiflexion.
timeFrame: 6 and 12 months after started treatment.
measure: Three-Dimensional Gait Analysis: time of heel-lift
timeFrame: 6 and 12 months after started treatment.
measure: Three-Dimensional Gait Analysis: jumping up and down
timeFrame: 6 and 12 months after started treatment.
measure: Balance measurement
timeFrame: 6 and 12 months after started treatment.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Physiotherapy and Orthopedical surgery, Copenhagen University Hospital, Amager-Hvidovre
state: Hvidovre
Study officials:
affiliation: Copenhagen University Hospital, Amager-Hvidovre
name: Maria S Hansen, PT, MSc
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.