NCT02044016

Brief Summary

The purpose of this study is 1) to develop and validate a new measurement to assess the length of the Achilles tendon after rupture, and 2) to examine if goniometer measurement of the ankle joint is a better method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

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

First Submitted

Initial submission to the registry

January 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

January 20, 2014

Last Update Submit

August 7, 2018

Conditions

Achilles Tendon Rupture

Keywords

Achilles tendon rupture, lengthening, validity, goniometer.

Outcome Measures

Primary Outcomes (1)

  • Achilles Tendon Length Measure (ATLM)

    The tester position one leg with a knee joint ankle to 90 degrees flexion. The other hand of the tester holds the ruler op against the foot. A plate in a hard, stiff wooden material is placed underneath the patient's thighs and knees. A ruler that is 100 cm long (25x5 mm) made in wood is being used. The tester is seated at the end of the examination coach. Besides observing the foot's position, we will measure the distances from points of reference on the foot to the examination coach. Points of reference: 1) The middle (and most prominent) point of the head of the fifth metatarsophalangeal head seen from the lateral side. 2) From the middle point of the lateral malleolus down to the examination coach).Take the first measure (metatarsophalangeal head-examination coach) and subtract this with the second one (lateral malleolus-examination coach). See if there is a difference between uninjured and injured side. Here you get the ATLM.

    8 weeks after injury

Secondary Outcomes (5)

  • Goniometer measurement of the angle in the ankle joint

    8 weeks after injury

  • Ultrasound

    8 weeks after injury

  • Goniometer measurement of the angle in the ankle joint

    16 weeks after injury

  • Ultrasound

    16 weeks after injury

  • Achilles Tendon Length Measure (ATLM)

    16 weeks after injury

Other Outcomes (6)

  • Achilles tendon Total Rupture Score

    A couple of days after date of injury

  • Heel-rise work test

    16 weeks after injury.

  • Heel-rise height test

    16 weeks after injury

  • +3 more other outcomes

Study Arms (1)

Observational study

To compare results of the ATLM with goniometry and Ultrasound measures of the achilles tendon.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with an acute achilles tendon rupture, between week 8 and 16 after injury. The patients are participating in a rehabilitation exercise group led by a physiotherapist 2 times a week for one hour at the time. Therefore, the patients in this study will be recruited from this program, and if they accept, they will be followed through the program, during the 2 examinations.

You may qualify if:

  • Patients aged 18-60.
  • Patients who are being referred to the rehabilitation program for patients with an AATR, at Hvidovre Hospital.
  • The patients have to speak and understand Danish.
  • The patients have to be able to sign the written informed consent.

You may not qualify if:

  • Patients who earlier have had a rupture of one or both AT.
  • Patients who have had an operation one of the achilles tendons before.
  • Patients who have been diagnosed with arterial insufficiency in legs.
  • Patients with a terminal disease or who suffers from a critical medical illness.
  • Patients where the distance from rupture to calcaneus is less than 1 cm (examined by palpation or in doubt, measured with an ultrasound)
  • Fluoroquinolone treatment within the last 6 months.
  • Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy, Hvidovre University Hospital

Copenhagen, Hvidovre, DK-2650, Denmark

Location

Study Officials

  • Maria Svennergren

    Hvidovre University Hospital Denmark, Department of Physiotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 23, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

DK(1)