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DELOAT: Delayed Loading Following Repair of a Ruptured Achilles Tendon

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04263493
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
28.4
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation (physiotheraphy)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial
Actual Study Start Date :
May 20, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Early mobilization (loading)

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

Other: Rehabilitation (physiotheraphy)
Time of loading, range of motion exercises, strength training
Experimental: Delayed mobilization (loading)

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

Other: Rehabilitation (physiotheraphy)
Time of loading, range of motion exercises, strength training

Outcome Measures

Primary Outcome Measures

  1. Heel-rise test [One-year follow-up]

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

Secondary Outcome Measures

  1. Tendon length and cross-sectional area [1 week, 3 months, 6 months and 1 year]

    MRI will be used to measure free tendon length, tendon cross-sectional area and tendon length up to the gastrocnemius insertion.

  2. The Achilles tendon rupture score (ATRS) [Recall before injury and 1 year]

    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.

  3. Muscle fascicle length and doppler activity in the tendon [2 weeks, 3 months, 6 months and 1 year]

    Muscle fascicle length and doppler activity in the tendon will be measured with ultrasonography

  4. Isokinetic plantar flexion muscle strength [1 year]

    The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.

  5. Physical activity level [Recall before injury and 1 year]

    A questionnaire is used to measure the physical activity level (including type of activity) of the participants.

  6. Heel-rise work [6 months and 1 year]

    An instrumented heel-rise test will be conducted to measure work capacity

  7. The Achilles tendon resting angle (ATRA) [2 weeks, 3 months, 6 months and 1 year]

    Achilles tendon resting angle will be measured using a standard goniometer. Measurements will be obtained with the knee flexed and extended.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bispebjerg Hospital Copenhagen Denmark 2400

Sponsors and Collaborators

  • Bispebjerg Hospital

Investigators

  • Principal Investigator: Peter Magnusson, Professor, Institute of Sportsmedicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rikke Høffner, PhD student, MSc, PT, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT04263493
Other Study ID Numbers:
  • 01012020
First Posted:
Feb 10, 2020
Last Update Posted:
Mar 3, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rikke Høffner, PhD student, MSc, PT, Bispebjerg Hospital
Achilles Tendon Surgery
Additional relevant MeSH terms:
Rupture

Study Results

No Results Posted as of Mar 3, 2022