Medium Term Outcome of Nonoperative Treatment After Achilles Tendon Rupture.

NCT02760784 | Completed DMC

• 1 other identifier: 16015461-1
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendon Rupture

Keywords

Achilles Tendon Rupture; Conservative treatment; early weight bearing; Dynamic; ATRS; ATRA; Heel Raise Work

Outcome Measures

Primary Outcomes (1)

• ATRS: Achilles Tendon Rupture Score

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

  approximate 5 years

Secondary Outcomes (2)

• Heel Raise Work

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

• return to sport and return to work

  4-5 years after the initial injury

Study Arms (2)

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

Early weight bearing BEHAVIORAL

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.

Early Weight Bearing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, Outside US/Canada/Australia, 2650, Denmark

Location

Related Publications (4)

• 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.

  PMID: 25232073 BACKGROUND

• 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.

  PMID: 35234975 DERIVED

• 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.

  PMID: 31276005 DERIVED

• 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.

  PMID: 30030579 DERIVED

Study Officials

• Jeannette Penny, MD, PhD

  Copenhagen University Hospital, Hvidovre

  STUDY DIRECTOR

• Rasmus Kastoft, Stud. Med.

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 4, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)