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

Bispebjerg Hospital

Status: Completed

Conditions: Achilles Tendon Rupture

Treatments: Other: Rehabilitation (physiotheraphy)

Study type: Interventional

Funder types: Other

Identifiers

NCT04263493

01012020

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Early mobilization (loading)

Active Comparator group

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

Treatment:

Other: Rehabilitation (physiotheraphy)

Delayed mobilization (loading)

Experimental group

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

Treatment:

Other: Rehabilitation (physiotheraphy)