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CompletedNCT02760784Updated Aug 10, 2017

Medium Term Outcome of Nonoperative Treatment After Achilles Tendon Rupture.

An observational study in Achilles Tendon Rupture, sponsored by Copenhagen University Hospital, Hvidovre. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-10.

Sponsored by Copenhagen University Hospital, Hvidovre · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
37
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Achilles Tendon Rupture

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Keywords

  • Achilles Tendon Rupture
  • Conservative treatment
  • early weight bearing
  • Dynamic
  • ATRS
  • ATRA
  • Heel Raise Work
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In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's enrollment of 37 is below the median of 100 across 203 observational studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Copenhagen University Hospital, Hvidovre is the lead sponsor of 76 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • Early Weight Bearing

    Ankle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Full weight bearing was allowed from day 1. The orthosis was worn 24 hours / day the first 2 weeks. From week 2 controlled motion exercises and removal of the orthosis 5 times a day.

    Behavioral: Early weight bearing

  • Control

    Ankle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Weight bearing was allowed from week 6. The orthosis was worn 24 hours / day the first 2 weeks. From week 2 controlled motion exercises and removal of the orthosis 5 times a day.

Interventions

  • BehavioralEarly 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.

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What researchers measure

Primary outcomes

  1. ATRS: Achilles Tendon Rupture Score

    From initial test 6 and 12 months after injury, and now 4-5 years after.

    Time frame: approximate 5 years

Secondary outcomes

  1. 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.

    Time frame: Test is performed once, 4-5 years after the initial injury

  2. 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.

    Time frame: 4-5 years after the initial injury

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Study locations

1 site
  • Hvidovre Hospital
    Hvidovre, Outside US/Canada/Australia 2650, Denmark
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References and documents

Publications

  • 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. PubMed 25232073 ↗
  • 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. PubMed 35234975 ↗
  • 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. PubMed 31276005 ↗
  • 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. PubMed 30030579 ↗

Individual participant data

Plan to share: No — No plan to share data

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02760784
Lead sponsor
Copenhagen University Hospital, Hvidovre
Responsible party
Rasmus Kastoft (Research Assistant, Copenhagen University Hospital, Hvidovre) — Principal investigator
First posted
May 4, 2016
Start date
Jan 2016
Primary completion
Jun 2016
Completion
Aug 2017
Last update
Aug 10, 2017

Study contacts

Jeannette Penny, MD, PhD
study director · Copenhagen University Hospital, Hvidovre
Rasmus Kastoft, Stud. Med.
principal investigator · Copenhagen University Hospital, Hvidovre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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