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

Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Other: Rehabilitation (physiotheraphy)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heel-rise test	Heel-rise height deficit on the injured side relative to the uninjured side	One-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week, 3 months, 6 months and 1 year
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.	Recall before injury and 1 year
Muscle fascicle length and doppler activity in the tendon	Muscle fascicle length and doppler activity in the tendon will be measured with ultrasonography	2 weeks, 3 months, 6 months and 1 year
Isokinetic plantar flexion muscle strength	The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.	1 year
Physical activity level	A questionnaire is used to measure the physical activity level (including type of activity) of the participants.	Recall before injury and 1 year
Heel-rise work	An instrumented heel-rise test will be conducted to measure work capacity	6 months and 1 year
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.	2 weeks, 3 months, 6 months and 1 year

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2020
• Primary Completion (ACTUAL): October 1, 2022
• Study Completion (ACTUAL): October 1, 2022

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (ACTUAL): February 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Achilles Tendon Surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 01012020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No