NCT04263493

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 20, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

February 6, 2020

Last Update Submit

February 9, 2023

Conditions

Achilles Tendon Rupture

Keywords

Achilles Tendon Surgery

Outcome Measures

Primary Outcomes (1)

  • Heel-rise test

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

    One-year follow-up

Secondary Outcomes (7)

  • Tendon length and cross-sectional area

    1 week, 3 months, 6 months and 1 year

  • The Achilles tendon rupture score (ATRS)

    Recall before injury and 1 year

  • Muscle fascicle length and doppler activity in the tendon

    2 weeks, 3 months, 6 months and 1 year

  • Isokinetic plantar flexion muscle strength

    1 year

  • Physical activity level

    Recall before injury and 1 year

  • +2 more secondary outcomes

Study Arms (2)

Early mobilization (loading)

ACTIVE COMPARATOR

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)

Delayed mobilization (loading)

EXPERIMENTAL

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)

Interventions

Rehabilitation (physiotheraphy)OTHER

Time of loading, range of motion exercises, strength training

Delayed mobilization (loading)Early mobilization (loading)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (2)

  • Hoeffner R, Svensson RB, Gillani SZ, Linden FH, Magnusson SP. Morphological Changes One Year After Achilles Tendon Rupture Repair: A Comparison of Loading Strategies. Transl Sports Med. 2025 Sep 28;2025:1778630. doi: 10.1155/tsm2/1778630. eCollection 2025.

    PMID: 41059465DERIVED

  • Hoeffner R, Agergaard AS, Svensson RB, Cullum C, Mikkelsen RK, Konradsen L, Krogsgaard M, Boesen M, Kjaer M, Magnusson SP. Tendon Elongation and Function After Delayed or Standard Loading of Surgically Repaired Achilles Tendon Ruptures: A Randomized Controlled Trial. Am J Sports Med. 2024 Mar;52(4):1022-1031. doi: 10.1177/03635465241227178. Epub 2024 Feb 14.

    PMID: 38353060DERIVED

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Peter Magnusson, Professor

    Institute of Sportsmedicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, MSc, PT

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

May 20, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)