Clinical trial NCT03525314: Development of Achilles Tendon Elongation and Its Effect on Physical Function the First Year After Rupture
Official title: Development of Achilles Tendon Elongation and Its Effect on Physical Function the First Year After Rupture: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendon Rupture
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated for acute Achilles tendon rupture at Amager-Hvidovre Hospital during the study period will be offered to participate in the study. The study cohort of study with uniqe clinical trials ID: Achilles HVH RCT is also included in this cohort.

Brief summary: The objective of this study is to examine how elongation of the Achilles tendon develops during the first year after rupture among patients with an Achilles tendon rupture, and how it affects physical function.

The aim is to define a cutoff of acceptable elongation dividing the patients who obtain normal physical function (Limb Symmetry Index \> 90%) from those who do not.

Patients treated both operatively and non-operatively will be included.


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 postexaminations.
* 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 Fluorquinolons 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: Copenhagen Achilles Length Measure
timeFrame: Evaluation method after 12 months of started treatment
Secondary outcomes:
measure: Copenhagen Achilles Length Measure
timeFrame: Evaluation method after 0-4 days, 3 weeks, 9 weeks, 4 months, 6 months of started treatment
measure: Indirectly, clinical Achilles tendon length estimate
timeFrame: Evaluation method after 9 weeks, 4, 6 and 12 months of started treatment.
measure: Achilles tendon Total Rupture Score (ATRS)
timeFrame: Evaluation method after 0-4 days, 3 weeks, 9 weeks, 4, 6 and 12 months of started treatment
measure: Heel-rise Work test
timeFrame: Evaluation method after 4, 6 and 12 months of started treatment.
measure: Calf circumference
timeFrame: Evaluation method after 9 weeks, 4, 6 and 12 months of started treatment
measure: MRI
timeFrame: After 1 year of the 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.