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.
Verified date | August 2017 |
Source | Copenhagen University Hospital, Hvidovre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital | Hvidovre | Outside US/Canada/Australia |
Lead Sponsor | Collaborator |
---|---|
Copenhagen University Hospital, Hvidovre |
Denmark,
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
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 |
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