Achilles tendon rupture - Copenhagen Achilles Length Measure

Primary investigator 

Marianne Toft Vestermark, MD PhD¹ (marianne.t@vestermark.dk)

Senior researcher 

Kristoffer Weisskirchner Barfod, MD PhD²

Study members

Maria Swennergren Hansen, PT, MSc, PhD student^2,3

Lars Ebskov, MD⁴

Per Hölmich, Professor, Chief Surgeon, DMSc²

Affiliations

1. Department of Orthopedic Surgery, Viborg Regional Hospital, Denmark.
2. Sports Orthopedic Research Center – Copenhagen, Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, Denmark.
3. Physical Medicine & Rehabilitation Research Copenhagen (PMR-C); Department of Physical and Occupational Therapy, and Clinical Research Centre, Copenhagen University Hospital Amager-Hvidovre, Denmark.
4. Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, Denmark.

About the study

This study investigates if it is possible to individualize treatment of acute Achilles tendon rupture by use of simple ultrasonographic measurements. It is a multicenter trial conducted at 3 hospitals in Denmark. 

300 patients with an acute Achilles tendon rupture aged 18-65 years visiting the outpatient clinic within the first 4 days after the injury (and without a previous rupture in one of their Achilles tendons) will randomly be allocated to one of the 3 groups (1:1:1 ratio): individualized treatment algorithm, operative (control) or non-operative treatment (control). 

The individualized treatment algorithm is based on an ultrasonographic assessment of the morphology of the rupture; firstly evaluating the overlap of tendon stumps and secondly elongation measured with Copenhagen Achilles Length Measure. 

The primary outcome is function of the leg measured with the Heel-rise work test. Secondary outcomes are measurements of tendon elongation, patient reported outcome measure and complications. Alongside this RCT, two additional studies are being conducted, read about it here and here.

Purpose of the study

To investigate if individualized treatment of acute Achilles tendon rupture is more effective than treating all patients either operatively or non-operatively.

Time plan 

Recruitment of patients started in June 2018 and is expected to span over 4 years.

ClinicalTrial.gov identifier

NCT03525964

Funded by 

The Department of Orthopedic Surgery and the Department of Physical and Occupational Therapy, Copenhagen University Hospital Hvidovre, Denmark. DJO Global Inc. Gigtforeningen. Amager-Hvidovre hospitals forskningsfond. Toyota-Fonden. Hospitalsenheden Midt. Fysioterapipraksisfonden.