NCT02318472

Brief Summary

The purpose of this study is to determine whether early mobilization after Achilles tendon rupture can speed up healing, prevent development of venous thromboembolism and improve patient outcome.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

5.3 years

First QC Date

December 9, 2014

Last Update Submit

March 5, 2024

Conditions

Achilles Tendon RuptureDeep Venous Thrombosis

Keywords

MicrodialysisPatient related outcomeHeel rise testImmobilizationfunctional mobilizationUltrasound

Outcome Measures

Primary Outcomes (1)

  • Deep venous thrombosis (DVT)

    At 2 and 6 weeks postoperatively the number of participants with DVT will be assessed by compression duplex ultrasound (CDU)

    Six weeks

Secondary Outcomes (19)

  • Functional outcome - muscular endurance tests (heel-rise)

    Four years

  • Patient-reported outcome - ATRS

    Four years

  • Patient-reported outcome - EQ-5D

    One year

  • Physical activity - PAS

    Four years

  • Patient-reported outcome - The Foot and Ankle Outcome Score (FAOS)

    One year

  • +14 more secondary outcomes

Other Outcomes (4)

  • Tendon healing using microdialysis

    Two weeks

  • Time to surgery

    Within 10 days

  • Surgeon sex

    Surgery is performed within 10 days after injury

  • +1 more other outcomes

Study Arms (2)

Early mobilization

EXPERIMENTAL

Functional mobilization initiated directly post-operative with a weight-bearing VACOped orthosis with adjustable range of motion of the ankle

Device: VACOped orthosis

Immobilization

ACTIVE COMPARATOR

Treatment as usual using plaster cast immobilization

Device: Plaster cast

Interventions

VACOped orthosisDEVICE

Weight-bearing orthosis with adjustable range of motion of the ankle

Early mobilization
Plaster castDEVICE

Lower limb plaster cast

Immobilization

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute unilateral ATR, operated on within 96 hours
  • Age between 18 and 75 years

You may not qualify if:

  • Inability to give informed consent
  • Current anticoagulation treatment (including high dose acetylsalicylic acid)
  • Planned follow-up at other hospital
  • Inability to follow instructions
  • Known kidney failure
  • Heart failure with pitting oedema
  • Thrombophlebitis
  • Thromboembolic event during the previous three months
  • Other surgery during the previous month
  • Known malignancy
  • Haemophilia; and pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska university Hospital

Stockholm, 17176, Sweden

Location

Related Publications (9)

  • Saarensilta A, Aufwerber S, Gravare Silbernagel K, Ackermann P. Early Tendon Morphology as a Biomarker of Long-term Patient Outcomes After Surgical Repair of Achilles Tendon Rupture: A Prospective Cohort Study. Orthop J Sports Med. 2023 Nov 6;11(11):23259671231205326. doi: 10.1177/23259671231205326. eCollection 2023 Nov.

    PMID: 37941888DERIVED

  • Chen J, Wang J, Hart DA, Zhou Z, Ackermann PW, Ahmed AS. Complement factor D regulates collagen type I expression and fibroblast migration to enhance human tendon repair and healing outcomes. Front Immunol. 2023 Sep 6;14:1225957. doi: 10.3389/fimmu.2023.1225957. eCollection 2023.

    PMID: 37744351DERIVED

  • Wu X, Chen J, Sun W, Hart DA, Ackermann PW, Ahmed AS. Network proteomic analysis identifies inter-alpha-trypsin inhibitor heavy chain 4 during early human Achilles tendon healing as a prognostic biomarker of good long-term outcomes. Front Immunol. 2023 Jul 6;14:1191536. doi: 10.3389/fimmu.2023.1191536. eCollection 2023.

    PMID: 37483617DERIVED

  • Aufwerber S, Silbernagel KG, Ackermann PW, Naili JE. Comparable Recovery and Compensatory Strategies in Heel-Rise Performance After a Surgically Repaired Acute Achilles Tendon Rupture: An In Vivo Kinematic Analysis Comparing Early Functional Mobilization and Standard Treatment. Am J Sports Med. 2022 Dec;50(14):3856-3865. doi: 10.1177/03635465221129284. Epub 2022 Nov 2.

    PMID: 36322396DERIVED

  • Chen J, Wang J, Hart DA, Ahmed AS, Ackermann PW. Complement factor D as a predictor of Achilles tendon healing and long-term patient outcomes. FASEB J. 2022 Jun;36(6):e22365. doi: 10.1096/fj.202200200RR.

    PMID: 35596679DERIVED

  • Aufwerber S, Edman G, Gravare Silbernagel K, Ackermann PW. Changes in Tendon Elongation and Muscle Atrophy Over Time After Achilles Tendon Rupture Repair: A Prospective Cohort Study on the Effects of Early Functional Mobilization. Am J Sports Med. 2020 Nov;48(13):3296-3305. doi: 10.1177/0363546520956677. Epub 2020 Sep 28.

    PMID: 32986466DERIVED

  • Aufwerber S, Heijne A, Edman G, Silbernagel KG, Ackermann PW. Does Early Functional Mobilization Affect Long-Term Outcomes After an Achilles Tendon Rupture? A Randomized Clinical Trial. Orthop J Sports Med. 2020 Mar 16;8(3):2325967120906522. doi: 10.1177/2325967120906522. eCollection 2020 Mar.

    PMID: 32206673DERIVED

  • Aufwerber S, Heijne A, Gravare Silbernagel K, Ackermann PW. High Plantar Force Loading After Achilles Tendon Rupture Repair With Early Functional Mobilization. Am J Sports Med. 2019 Mar;47(4):894-900. doi: 10.1177/0363546518824326. Epub 2019 Feb 11.

    PMID: 30742483DERIVED

  • Alim MA, Svedman S, Edman G, Ackermann PW. Procollagen markers in microdialysate can predict patient outcome after Achilles tendon rupture. BMJ Open Sport Exerc Med. 2016 Jun 10;2(1):e000114. doi: 10.1136/bmjsem-2016-000114. eCollection 2016.

    PMID: 27900179DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Paul W Ackermann, MD, PhD

    Karolinska University Hospital

    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
Associate Professor, MD, PhD

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 17, 2014

Study Start

November 1, 2013

Primary Completion

March 1, 2019

Study Completion

December 1, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

SE(1)