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Delayed Loading Following Repair of a Ruptured Achilles Tendon (DELOAT)

Primary Purpose

Achilles Tendon Rupture

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Rehabilitation (physiotheraphy)
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Achilles Tendon Surgery

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with a traumatic, complete mid-substance Achilles tendon
  • No contraindications for MRI
  • Presented within 14 days from injury
  • Adult (18 to 60 years)
  • Understand Danish
  • Manage transport to/from the hospital on their own

Exclusion Criteria:

  • Other injuries affecting their lower limb functions
  • Prior Achilles tendon Rupture
  • Smoking
  • Systemic diseases influencing tendon healing
  • Anticoagulation treatment
  • Inability to follow rehabilitation or complete follow-ups
  • Immunosuppressive treatment including systematic corticosteroid treatment

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Early mobilization (loading)

Delayed mobilization (loading)

Arm Description

This constitutes the currently accepted regime and is therefore considered the control group. Cast/orthopedic boot for 6 weeks No weight bearing: week 0-2 Partiel weightbearing from week 3 Full weightbearing from week 7 ROM exercises 5 times a day from week 3

Loading of the Achilles tendon is delayed for 6 weeks. Cast/orthopedic boot for 12 weeks No weight bearing: week 0-6 Partiel weightbearing from week 7 Full weightbearing from week 13 ROM exercises 5 times a day from week 3

Outcomes

Primary Outcome Measures

Heel-rise test
Heel-rise height deficit on the injured side relative to the uninjured side

Secondary Outcome Measures

Tendon length and cross-sectional area
MRI will be used to measure free tendon length, tendon cross-sectional area and tendon length up to the gastrocnemius insertion.
The Achilles tendon rupture score (ATRS)
The Achilles tendon rupture score questionnaire is a patient-reported outcome with a possible score from 1-100, where higher scores mean a better outcome.
Muscle fascicle length and doppler activity in the tendon
Muscle fascicle length and doppler activity in the tendon will be measured with ultrasonography
Isokinetic plantar flexion muscle strength
The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.
Physical activity level
A questionnaire is used to measure the physical activity level (including type of activity) of the participants.
Heel-rise work
An instrumented heel-rise test will be conducted to measure work capacity
The Achilles tendon resting angle (ATRA)
Achilles tendon resting angle will be measured using a standard goniometer. Measurements will be obtained with the knee flexed and extended.

Full Information

First Posted
February 6, 2020
Last Updated
February 9, 2023
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04263493
Brief Title
Delayed Loading Following Repair of a Ruptured Achilles Tendon
Acronym
DELOAT
Official Title
Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year. The investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
Achilles Tendon Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early mobilization (loading)
Arm Type
Active Comparator
Arm Description
This constitutes the currently accepted regime and is therefore considered the control group. Cast/orthopedic boot for 6 weeks No weight bearing: week 0-2 Partiel weightbearing from week 3 Full weightbearing from week 7 ROM exercises 5 times a day from week 3
Arm Title
Delayed mobilization (loading)
Arm Type
Experimental
Arm Description
Loading of the Achilles tendon is delayed for 6 weeks. Cast/orthopedic boot for 12 weeks No weight bearing: week 0-6 Partiel weightbearing from week 7 Full weightbearing from week 13 ROM exercises 5 times a day from week 3
Intervention Type
Other
Intervention Name(s)
Rehabilitation (physiotheraphy)
Intervention Description
Time of loading, range of motion exercises, strength training
Primary Outcome Measure Information:
Title
Heel-rise test
Description
Heel-rise height deficit on the injured side relative to the uninjured side
Time Frame
One-year follow-up
Secondary Outcome Measure Information:
Title
Tendon length and cross-sectional area
Description
MRI will be used to measure free tendon length, tendon cross-sectional area and tendon length up to the gastrocnemius insertion.
Time Frame
1 week, 3 months, 6 months and 1 year
Title
The Achilles tendon rupture score (ATRS)
Description
The Achilles tendon rupture score questionnaire is a patient-reported outcome with a possible score from 1-100, where higher scores mean a better outcome.
Time Frame
Recall before injury and 1 year
Title
Muscle fascicle length and doppler activity in the tendon
Description
Muscle fascicle length and doppler activity in the tendon will be measured with ultrasonography
Time Frame
2 weeks, 3 months, 6 months and 1 year
Title
Isokinetic plantar flexion muscle strength
Description
The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.
Time Frame
1 year
Title
Physical activity level
Description
A questionnaire is used to measure the physical activity level (including type of activity) of the participants.
Time Frame
Recall before injury and 1 year
Title
Heel-rise work
Description
An instrumented heel-rise test will be conducted to measure work capacity
Time Frame
6 months and 1 year
Title
The Achilles tendon resting angle (ATRA)
Description
Achilles tendon resting angle will be measured using a standard goniometer. Measurements will be obtained with the knee flexed and extended.
Time Frame
2 weeks, 3 months, 6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with a traumatic, complete mid-substance Achilles tendon No contraindications for MRI Presented within 14 days from injury Adult (18 to 60 years) Understand Danish Manage transport to/from the hospital on their own Exclusion Criteria: Other injuries affecting their lower limb functions Prior Achilles tendon Rupture Smoking Systemic diseases influencing tendon healing Anticoagulation treatment Inability to follow rehabilitation or complete follow-ups Immunosuppressive treatment including systematic corticosteroid treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Magnusson, Professor
Organizational Affiliation
Institute of Sportsmedicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Delayed Loading Following Repair of a Ruptured Achilles Tendon

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