Delayed Loading Following Repair of a Ruptured Achilles Tendon

Achilles Tendon Rupture Clinical Trial

— DELOAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263493
• Other study ID #: 01012020
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

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

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heel-rise test	Heel-rise height deficit on the injured side relative to the uninjured side	One-year follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Isokinetic plantar flexion muscle strength	The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.	1 year
Secondary	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
Secondary	Heel-rise work	An instrumented heel-rise test will be conducted to measure work capacity	6 months and 1 year
Secondary	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