NCT04420832

Brief Summary

Patients with acute achilles tendon rupture will go through an acute ultrasound. Based on the distance between the ends of the tendon the investigators will decide if the patient is going to be treated with or without surgery.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Aug 2020

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 Progress81%
Aug 2020Aug 2027

First Submitted

Initial submission to the registry

May 17, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

7.1 years

First QC Date

May 17, 2020

Last Update Submit

May 28, 2024

Conditions

Achilles Tendon RuptureAthletic InjuriesUltrasonographyRuptureAcute Disease

Outcome Measures

Primary Outcomes (4)

  • Difference in functional outcome between patients treated surgically and non-surgically

    The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated test which combines both the height of each heel-rise and the number of repetitions.

    3 months

  • Difference in functional outcome between patients treated surgically and non-surgically

    The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance

    6 months

  • Difference in functional outcome between patients treated surgically and non-surgically

    The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance

    12 months

  • Difference in functional outcome between patients treated surgically and non-surgically

    The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance

    24 months

Secondary Outcomes (11)

  • Ultrasonography (US)

    6 months

  • Ultrasonography (US)

    12 months

  • Ultrasonography (US)

    24 months

  • Achilles Tendon Rupture Score (ATRS)

    3 months

  • Achilles Tendon Rupture Score (ATRS)

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Surgical treatment

ACTIVE COMPARATOR

Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy

Procedure: Surgical treatment

Non-surgical treatment

OTHER

Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy

Other: Non-surgical treatment

Interventions

Surgical treatmentPROCEDURE

Se above

Surgical treatment
Non-surgical treatmentOTHER

See above

Non-surgical treatment

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • acute achilles tendon rupture diagnosed less than 48 hours from injury
  • mid-substance rupture

You may not qualify if:

  • previous achilles tendon rupture
  • lower leg disability
  • diabetes mellitus
  • neurovascular disease
  • immunosuppression
  • non-Swedish speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedics

Gothenburg, Västra Götalandsregionen, Sweden

Location

MeSH Terms

Conditions

Athletic InjuriesRuptureAcute Disease

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katarina Nilsson Helander, MD Ass Prof.

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 17, 2020

First Posted

June 9, 2020

Study Start

August 1, 2020

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations

SE(1)