NCT06723639

Brief Summary

The goal of this clinical trial is to investigate a new surgical approach to restore the anatomy of a ruptured Achilles tendon. We will use a new two-layer technique followed by rehabilitation and find out how it influence the patients clinical outcome, muscle and tendon structure, and function after one year and compare with a standard non-surgical approach followed by rehabilitation. Participants will be randomized to 1) NEWSUR: A new two-layer surgical technique followed by rehabilitation regime or 2) CONSER: A standard non-surgical treatment followed by rehabilitation . We hypothesize that restoring the anatomy of the ruptured mid-substance Achilles tendon using a new two-layer surgery technique followed by rehabilitation will yield a more favorable patient reported outcome (ATRS) one year after rupture compared to standard non-surgical treatment followed by rehabilitation.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Feb 2025Jul 2027

First Submitted

Initial submission to the registry

December 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 15, 2025

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

December 4, 2024

Last Update Submit

April 11, 2025

Conditions

Achilles Tendon Rupture

Keywords

Achilles tendon ruptureMRISurgeryRestore anatomyHeel-rise testRehabilitation

Outcome Measures

Primary Outcomes (1)

  • The Achilles tendon Total rupture score (ATRS)

    The Achilles tendon Total rupture score (ATRS) will be used. The ATRS is a patient-reported instrument with high reliability, validity, and sensitivity for measuring the outcome related to symptoms and physical activity after treatment in patients with a total Achilles tendon rupture. The scale is from 0-100. A score of 100 points indicates full function and no pain with lower scores indicating reduced function.

    At 1 year

Secondary Outcomes (10)

  • Hourly sporting activity

    1 year

  • Patient satisfaction

    1 year

  • Tampa Scale of Kinesiophobia

    26 weeks & 1 year

  • Heel-rise test

    26 weeks & 1 year

  • Ultrasonography

    1 year

  • +5 more secondary outcomes

Study Arms (2)

NEWSUR

EXPERIMENTAL

Participants in this group will receive a new two-layer surgical technique followed by a detailed rehabilitation regime.

Procedure: A new two-layer surgical technique

CONSER

OTHER

Participants in this group will receive standard non-surgical treatment followed by a detailed rehabilitation regime.

Other: Standard non-surgical treatment

Interventions

A new two-layer surgical techniquePROCEDURE

A new double row suturing technique attempting to restore the length of the distinct soleus and gastrocnemius portions of the Achilles tendon.

Also known as: Repair, Sutur, Operation
NEWSUR
Standard non-surgical treatmentOTHER

Standard non-surgical treatment

Also known as: Standard, Conservative, No surgery
CONSER

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with a complete mid-substance Achilles tendon rupture based on clinical exam, including Thompson/Matles test, by an experienced physician.
  • Presented within 14 days from injury.
  • Understands and reads Danish.
  • No contraindications for MRI.

You may not qualify if:

  • Smoking
  • Diabetes
  • Other injuries affecting their lower limb function.
  • Contralateral Achilles tendon rupture.
  • Re-rupture.
  • Anticoagulation treatment.
  • Inability to follow rehabilitation or complete follow-up tests.
  • Immunosuppressive treatment, including systemic corticosteroid treatment.
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.

Copenhagen, Capital, 2400, Denmark

RECRUITING

Copenhagen University Hospital, Amager-Hvidovre

Copenhagen, Capital, Denmark

NOT YET RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

NOT YET RECRUITING

MeSH Terms

Interventions

Wound HealingSuturesSurgical Procedures, OperativeConservative Treatment

Intervention Hierarchy (Ancestors)

RegenerationBiological PhenomenaSurgical Fixation DevicesSurgical EquipmentEquipment and SuppliesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doc, PhD, PT

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 9, 2024

Study Start

February 28, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 15, 2025

Record last verified: 2024-11

Locations

SE(1)DK(2)