NCT02805751

Brief Summary

The purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA). The hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

August 10, 2021

Status Verified

June 1, 2016

Enrollment Period

3.1 years

First QC Date

June 10, 2016

Last Update Submit

August 3, 2021

Conditions

Tendon InjuriesSoft Tissue InjuriesAchilles Tendon Rupture

Keywords

AchillesTendonLoadingRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Modulus of Elasticity

    Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.

    19 weeks

Secondary Outcomes (7)

  • Tendon elongation

    2, 7, 19 and 52 weeks after rupture

  • Modulus of Elasticity

    7 and 52 weeks after rupture

  • Achilles tendon total rupture score (ATRS)

    19 and 52 weeks after rupture

  • Maximal range of motion

    19 and 52 weeks after rupture

  • Heel-rise

    19 and 52 weeks after rupture

  • +2 more secondary outcomes

Study Arms (2)

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 weight-bearing as tolerated from day 0. They are also instructed to perform tendon strain exercises 3 times each day from 2 weeks after the rupture.

Other: Tendon strain exercisesOther: Early weight bearing

Early loading

EXPERIMENTAL

The patients in the early loading group are also allowed to have weight-bearing as tolerated from day 0 and perform tendon strain exercises 3 times each day from 2 weeks after the rupture. The patients in this group will also remove the walker twice a day and use a special training pedal for 5 weeks (until walker removal).

Device: Early loading on a training pedalOther: Tendon strain exercisesOther: Early weight bearing

Interventions

Early loading on a training pedalDEVICE

The patients will perform early loading by using a special training pedal for 5 weeks, starting 2 weeks after the rupture. The patients will remove the walker and train twice a day on this pedal.

Early loading
Tendon strain exercisesOTHER

The patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture.

ControlEarly loading
Early weight bearingOTHER

The patients are allowed to bear weight as much as tolerated in the walker from day 1.

ControlEarly loading

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Inability to understand swedish
  • previous injured tendon
  • Diabetes mellitus
  • History of Rheumatoid disease
  • Treatment with steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Linkoeping

Linköping, Östergötland County, 58729, Sweden

Location

Related Publications (1)

  • Rendek Z, Bon Beckman L, Schepull T, Danmark I, Aspenberg P, Schilcher J, Eliasson P. Early Tensile Loading in Nonsurgically Treated Achilles Tendon Ruptures Leads to a Larger Tendon Callus and a Lower Elastic Modulus: A Randomized Controlled Trial. Am J Sports Med. 2022 Oct;50(12):3286-3298. doi: 10.1177/03635465221117780. Epub 2022 Aug 25.

    PMID: 36005394DERIVED

MeSH Terms

Conditions

Tendon InjuriesSoft Tissue Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Per Aspenberg, MD, PhD

    Linkoeping University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 20, 2016

Study Start

October 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2019

Last Updated

August 10, 2021

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)