Clinical trial NCT02760784: Medium Term Outcome of Nonoperative Treatment After Achilles Tendon Rupture.
Official title: Medium Term Outcome of Nonoperative Dynamic Treatment of Acute Achilles Tendon Rupture: the Influence of Early Weight-bearing on Clinical Outcome: a Blinded, Randomized Controlled Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendon Rupture
Keywords: Achilles Tendon Rupture
Conservative treatment
early weight bearing
Dynamic
ATRS
ATRA
Heel Raise Work
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who participated and completed the original study:

Barfod, K.W., et al., Nonoperative dynamic treatment of acute achilles tendon rupture: the influence of early weight-bearing on clinical outcome: a blinded, randomized controlled trial. J Bone Joint Surg Am, 2014. 96(18): p. 1497-503.

Brief summary: A total of 56 patients completed a previous study regarding non-operative treatment for acute achilles tendon rupture. This study consists of an additional follow up after 4-5 years depending on original date of injury.

Detailed description: 30 patients suffering from acute Achilles tendon rupture was originally randomized to each arm, and followed up after 6 and 12 months. Of these a total of 56 patients was included in the final analysis, and invited to participate in this additional follow-up, 4-5 years after their original injury. Originally patients was monitored using: ATRS questionnaires, ATRA: Achilles Tendon Resting Angle, Heel Raise Work: number of lifts, lift height and total work, and tests of strength and stiffness in the ankle using a kinetic dynamometer.

Eligibility criteria: Inclusion Criteria:

* Suffered acute Achilles tendon rupture from April 2011 to March 2012, and then referred to Copenhagen University Hospital Hvidovre.
* Participated and completed the original study.
* The patient must be able to speak and understand Danish, as well as be capable to give informed consent to participating.

Exclusion Criteria:

* Terminal disease or serious illnesses with an ASA score of 3 or above.
* Any injury significantly influencing gate and function of the lower extremities other than re-rupture of the Achilles tendon.

Primary outcomes:
measure: ATRS: Achilles Tendon Rupture Score
timeFrame: approximate 5 years
Secondary outcomes:
measure: Heel Raise Work
timeFrame: Test is performed once, 4-5 years after the initial injury
measure: return to sport and return to work
timeFrame: 4-5 years after the initial injury
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Outside US/Canada/Australia
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Jeannette Penny, MD, PhD
role: STUDY_DIRECTOR
affiliation: Copenhagen University Hospital, Hvidovre
name: Rasmus Kastoft, Stud. Med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barfod KW, Bencke J, Lauridsen HB, Ban I, Ebskov L, Troelsen A. Nonoperative dynamic treatment of acute achilles tendon rupture: the influence of early weight-bearing on clinical outcome: a blinded, randomized controlled trial. J Bone Joint Surg Am. 2014 Sep 17;96(18):1497-503. doi: 10.2106/JBJS.M.01273.
citation: Kastoft R, Barfod K, Bencke J, Speedtsberg MB, Hansen SB, Penny JO. 1.7 cm elongated Achilles tendon did not alter walking gait kinematics 4.5 years after non-surgical treatment. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3579-3587. doi: 10.1007/s00167-022-06874-y. Epub 2022 Mar 2.
citation: Speedtsberg MB, Kastoft R, Barfod KW, Penny JO, Bencke J. Gait Function and Postural Control 4.5 Years After Nonoperative Dynamic Treatment of Acute Achilles Tendon Ruptures. Orthop J Sports Med. 2019 Jun 27;7(6):2325967119854324. doi: 10.1177/2325967119854324. eCollection 2019 Jun.
citation: Kastoft R, Bencke J, Speedtsberg MB, Penny JO, Barfod K. Early weight-bearing in nonoperative treatment of acute Achilles tendon rupture did not influence mid-term outcome: a blinded, randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2019 Sep;27(9):2781-2788. doi: 10.1007/s00167-018-5058-4. Epub 2018 Jul 20.