NCT02422004

Brief Summary

The overall aim of this project is to investigate the healing processes of human tendon after suturing a ruptured Achilles tendon, and more specifically to determine the optimal loading pattern of the tendon during the rehabilitation period to ensure complete and good recovery of tendon structure and function. The investigators hypothesize that restricting early weight bearing and only allowing for passive stretching in the early phase of tendon healing will ensure better tissue regeneration and thereby prevent chronic tendon elongation and improve tendon tissue recovery and the clinical outcome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

4.1 years

First QC Date

April 16, 2015

Last Update Submit

April 20, 2015

Conditions

Achilles Tendon Rupture

Keywords

RehabilitationWeight-bearingRange of motion

Outcome Measures

Primary Outcomes (1)

  • Tendon elongation

    Tendon elongation will be evaluated using x-ray and measurements of the distance between tantalum beads

    2, 6, 12, 26 and 52 weeks after rupture

Secondary Outcomes (8)

  • Heel-rise

    26 and 52 weeks after rupture

  • Achilles tendon total rupture score (ATRS)

    12, 26 and 52 weeks after rupture

  • Elastic modulus of the tendon

    6, 26 and 52 weeks after rupture

  • Range of motion test

    26 and 52 weeks after rupture

  • Victorian Institute of Sport Assessment questionnaire - Achilles tendinopathy (VISA-A)

    12, 26 and 52 weeks after rupture

  • +3 more secondary outcomes

Study Arms (3)

Control

ACTIVE COMPARATOR

This constitutes the currently accepted regime and is therefore consider the control group (CTRL) with early range of motion and early weight bearing. The control group was allowed to have partial weight-bearing from day 0 and full weight-bearing from week 4. Furthermore, they were instructed in tendon strain exercise identical with the range of motion group.

Other: Range of motion

Range of motion

EXPERIMENTAL

Early range of motion and delayed weight bearing (ROM). The range of motion group was restricted completely from weight-bearing until week 6, allowed partial weight-bearing after 6 weeks and full weight-bearing after 8 weeks. In addition to this, the patients were instructed to perform tendon strain exercises, five times a day, from week 2. The exercises were performed by removing the foot from the brace and then perform light dorsal ankle movement, 25 repetitions/time, when sitting on a table.

Other: Range of motionOther: Delayed weight-bearing

Immobilization

EXPERIMENTAL

Delayed weight-bearing or range of motion (IMMOB). The immobilization group was restricted completely from weight-bearing until week 6, allowed partial weight-bearing after 6 weeks and full weight-bearing after 8 weeks.

Other: Delayed weight-bearing

Interventions

Range of motionOTHER

25 range of motion exercises of the ankle, 5 times per day.

ControlRange of motion
Delayed weight-bearingOTHER

No weight-bearing during the first six weeks, and partial weight-bearing during the two following weeks

ImmobilizationRange of motion

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
  • Presented within 14 days from injury

You may not qualify if:

  • re-rupture
  • other injuries affecting their lower limb functions
  • systemic diseases influencing tendon healing
  • immunosuppressive treatment including systemic corticosteroid treatment
  • inability to follow rehabilitation or follow-ups.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

RECRUITING

Related Publications (7)

  • Magnusson SP, Narici MV, Maganaris CN, Kjaer M. Human tendon behaviour and adaptation, in vivo. J Physiol. 2008 Jan 1;586(1):71-81. doi: 10.1113/jphysiol.2007.139105. Epub 2007 Sep 13.

    PMID: 17855761BACKGROUND

  • Maffulli N, Waterston SW, Squair J, Reaper J, Douglas AS. Changing incidence of Achilles tendon rupture in Scotland: a 15-year study. Clin J Sport Med. 1999 Jul;9(3):157-60. doi: 10.1097/00042752-199907000-00007.

    PMID: 10512344BACKGROUND

  • Saxena A, Ewen B, Maffulli N. Rehabilitation of the operated achilles tendon: parameters for predicting return to activity. J Foot Ankle Surg. 2011 Jan-Feb;50(1):37-40. doi: 10.1053/j.jfas.2010.10.008. Epub 2010 Nov 24.

    PMID: 21106412BACKGROUND

  • Andersson T, Eliasson P, Aspenberg P. Tissue memory in healing tendons: short loading episodes stimulate healing. J Appl Physiol (1985). 2009 Aug;107(2):417-21. doi: 10.1152/japplphysiol.00414.2009. Epub 2009 Jun 18.

    PMID: 19541735BACKGROUND

  • Mortensen HM, Skov O, Jensen PE. Early motion of the ankle after operative treatment of a rupture of the Achilles tendon. A prospective, randomized clinical and radiographic study. J Bone Joint Surg Am. 1999 Jul;81(7):983-90. doi: 10.2106/00004623-199907000-00011.

    PMID: 10428130BACKGROUND

  • Kangas J, Pajala A, Ohtonen P, Leppilahti J. Achilles tendon elongation after rupture repair: a randomized comparison of 2 postoperative regimens. Am J Sports Med. 2007 Jan;35(1):59-64. doi: 10.1177/0363546506293255. Epub 2006 Sep 14.

    PMID: 16973901BACKGROUND

  • Eliasson P, Agergaard AS, Couppe C, Svensson R, Hoeffner R, Warming S, Warming N, Holm C, Jensen MH, Krogsgaard M, Kjaer M, Magnusson SP. The Ruptured Achilles Tendon Elongates for 6 Months After Surgical Repair Regardless of Early or Late Weightbearing in Combination With Ankle Mobilization: A Randomized Clinical Trial. Am J Sports Med. 2018 Aug;46(10):2492-2502. doi: 10.1177/0363546518781826. Epub 2018 Jul 2.

    PMID: 29965789DERIVED

MeSH Terms

Interventions

Range of Motion, Articular

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Peter Magnusson, PT, DSc, PhD

    Bispebjerg Hospital, University of Copenhagen

    STUDY DIRECTOR

  • Michael Kjaer, MD, PhD

    Bispebjerg Hospital, University of Copenhagen

    STUDY DIRECTOR

Central Study Contacts

Pernilla Eliasson, PhD

CONTACT

+46739864982pernilla.eliasson@gmail.com

Anne-Sofie Andersen, PT, MSc

CONTACT

+4535315059a_sofie_a@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 21, 2015

Study Start

August 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

DK(1)