Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures

Achilles Tendon Rupture Clinical Trial

Official title:

Mechanical Properties in Conservative Treated Achilles Tendon Ruptures With or Without Early Controlled Loading

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805751
• Other study ID #: Early loading
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: November 2019

Study information

• Verified date: June 2016
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA). The hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.

Description:

Treatment of Achilles tendon ruptures includes surgical repair or immobilization in an orthosis, followed by prolonged rehabilitation. Improved rehabilitation regimens still display imperfect recovery, with deficits such as persistent end-range muscle weakness, tendon elongation and incomplete return to pre-injury activity level. The underlying mechanisms are unknown, but are likely to involve molecular and cellular aspects of the early healing processes. Animal experiments have shown that short episodes of vigorous loading during tendon healing create a stronger tendon, and lead to less elongation than continuous loading. Early controlled training has also been shown to improve the material properties of surgically repaired tendons. However, more and more clinics now turn away from surgery and towards conservative treatment, while studies on rehabilitation mainly concern sutured tendons. It is therefore also important to understand how to best rehabilitate conservatively treated patients. The aim is to investigate the effect of early controlled loading on conservatively treated Achilles tendon ruptures. The patients (age 18-60 years of age) are treated conservatively by receiving a removable foam walker boot at the emergency department. The patients are thereafter called by the principal investigator and are asked if they want to participate in the study. Patients who are interested in participating in the study receive oral and in written information about the study of the principal investigator of the study (Pernilla Eliasson). After 2 weeks, the rupture is localized by ultrasound and 4 tantalum beads are implanted percutaneously in the proximal and distal part of the tendon. These beads are used for measurements of the mechanical properties of the tendon by using RSA. The patients are thereafter randomized to early controlled loading or control. All patients wear the foam walker boot for 7 weeks. Full weight-bearing is allowed as tolerated from the beginning. Both groups perform motion exercises outside the boot with 20 repetitions, 3 times per day as of 14 days after rupture. The patients in the early loading group are provided with a special training pedal where pedal resistance can be increased during the treatment period. The patients will use this pedal twice a day starting 2 weeks after rupture. After the initial 7 weeks, the patients are referred to physical therapists uninvolved in this research, but with the instruction to follow the regional rehabilitation guidelines for Achilles tendon ruptures. Mechanical properties of the tendon will be estimated by measuring tendon length, cross-sectional area (CSA) and stiffness at week 7, 19 and 52. The elastic modulus of the tendon at 19 weeks it the primary variable of this study. At week 7, both the elastic and plastic deformation will be measured. Tendon CSA will be evaluated using computer tomography (CT). Tendon elongation will be evaluated by RSA at week 2, 7, 19 and 52. Calf muscle circumference, passive and active range of motion in the ankle joint and a heel-raise test will be performed at week 19 and 52. The overall function will be assessed by the Achilles Tendon Rupture Score at 19 and 52 weeks. Complications and re-ruptures will be registered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
• Presented within 14 days from injury
• 18-60 years old

Exclusion Criteria:

• Inability to understand swedish
• previous injured tendon
• Diabetes mellitus
• History of Rheumatoid disease
• Treatment with steroids

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture
• Soft Tissue Injuries
• Tendon Injuries
• Wounds and Injuries

Intervention

Device:
• Early loading on a training pedal
The patients will perform early loading by using a special training pedal for 5 weeks, starting 2 weeks after the rupture. The patients will remove the walker and train twice a day on this pedal.

Other:
• Tendon strain exercises
The patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture.
• Early weight bearing
The patients are allowed to bear weight as much as tolerated in the walker from day 1.

Locations

Country	Name	City	State
Sweden	University Hospital Linkoeping	Linkoping	Ostergotland

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modulus of Elasticity	Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.	19 weeks
Secondary	Tendon elongation	Tendon elongation will be evaluated using RSA and measurements of the distance between tantalum beads	2, 7, 19 and 52 weeks after rupture
Secondary	Modulus of Elasticity	Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.	7 and 52 weeks after rupture
Secondary	Achilles tendon total rupture score (ATRS)	Patient reported outcome regarding function in their Achilles tendon	19 and 52 weeks after rupture
Secondary	Maximal range of motion	The maximun range of motion in the ankle joint will be measured in plantar and dorsiflexion.	19 and 52 weeks after rupture
Secondary	Heel-rise	The number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.	19 and 52 weeks after rupture
Secondary	Plastic deformation of the tendon	Plastic deformation will be measured using RSA and measurements of the distance between tantalum beads while the patient continues to have a load on the tendon for 3 minutes with a weight. Tendon size will be measured using CT.	7 weeks after rupture
Secondary	Calf muscle circumference	Measurement of the circumference at the thickest part of the calf	19 and 52 weeks