Medium Term Outcome of Nonoperative Treatment After Achilles Tendon Rupture.

Achilles Tendon Rupture Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760784
• Other study ID #: 16015461-1
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: August 9, 2017
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Behavioral:
• Early weight bearing
The intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks.

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre	Outside US/Canada/Australia

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ATRS: Achilles Tendon Rupture Score	From initial test 6 and 12 months after injury, and now 4-5 years after.	approximate 5 years
Secondary	Heel Raise Work	The total work (joules), max height of lift (mm) and number of lifts is recorded. THe patient is placed standing on one leg on a platform tilted 10 degrees (heel below toes), and is asked to lift the heel (and thereby bodyweight) as high as possible, once every 2 seconds. When the patient can no longer maintain height or pace, the test is finished.	Test is performed once, 4-5 years after the initial injury
Secondary	return to sport and return to work	When did the patients return to work full or part time, and when did they take up sports again.	4-5 years after the initial injury