Delayed Loading Following Repair of a Ruptured Achilles Tendon

Not Applicable

Completed

• Conditions: Achilles Tendon Rupture
• Interventions: Other: Rehabilitation (physiotheraphy)

• Registration Number: NCT04263493
• Lead Sponsor: Bispebjerg Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Study Start: 2020-05-20
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early mobilization (loading)	Rehabilitation (physiotheraphy)	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
Delayed mobilization (loading)	Rehabilitation (physiotheraphy)	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

Primary Outcome Measures

Name	Time	Method
Heel-rise test	One-year follow-up	Heel-rise height deficit on the injured side relative to the uninjured side

Secondary Outcome Measures

Name	Time	Method
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.
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.
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
Isokinetic plantar flexion muscle strength	1 year	The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.
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.
Heel-rise work	6 months and 1 year	An instrumented heel-rise test will be conducted to measure work capacity
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.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark