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Healing of Human Achilles Tendon Rupture

Healing of Human Achilles Tendon Rupture: Loading Pattern After Surgical Repair to Achieve Optimal Mechanical Properties and Clinical Outcome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02422004
Enrollment
75
Registered
2015-04-21
Start date
2012-08-31
Completion date
2016-09-30
Last updated
2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendon Rupture

Keywords

Rehabilitation, Weight-bearing, Range of motion

Brief summary

The overall aim of this project is to investigate the healing processes of human tendon after suturing a ruptured Achilles tendon, and more specifically to determine the optimal loading pattern of the tendon during the rehabilitation period to ensure complete and good recovery of tendon structure and function. The investigators hypothesize that restricting early weight bearing and only allowing for passive stretching in the early phase of tendon healing will ensure better tissue regeneration and thereby prevent chronic tendon elongation and improve tendon tissue recovery and the clinical outcome.

Detailed description

Surgical repair of Achilles tendon ruptures is known to significantly reduce the risk of re-rupture and to accelerate the time to return to activity compared with non-surgical treatments (1, 2). Although sutured, Achilles tendon rupture requires an extended rehabilitation period following surgery to function normally again. However, the currently available information on this post-operative treatment suggest that the currently available rehabilitation guidelines, which includes early weight bearing, does not accomplish optimal recovery of muscle-tendon function. It has been demonstrated that reduced capacity to perform heel-rises, diminished range of motion of the ankle joint, and reduced calf muscle mass is correlated with a delay in return to activity, and all of these factors could be related to elongation of the healing tendon (3). Importantly, it appears that preventing tendon elongation during rehabilitation improves the clinical outcome, but the actual mechanism for the elongation and thus how to prevent it remains unknown (4). With newly developed techniques in our laboratory we will determine the mechanical properties of human whole Achilles tendon, in vivo, which makes it possible to explore how tendons respond to the regimes following a suture repair and rehabilitation regime. In contrast to the current rehabilitation regime after tendon surgery, which includes early high loading (weight bearing) already in the first weeks after surgery, we hypothesize that avoiding early weight bearing but allowing for early passive ankle joint range of motion (tissue strain with minimal loading) will prevent chronic tendon elongation, increase tendon stiffness, increase calf strength and muscle volume/thickness, and thus improve the long-term clinical outcome after tendon rupture in humans. Patients with acute Achilles tendon ruptures will undergo a standardized suture repair (a.m. Kessler) using resorbable suture (Vicryl size 1) at Bispebjerg Hospital and be placed in a brace that inhibits ankle joint movement. During surgery, patients will get four tantalum beads with a diameter of 1.0 mm implanted with a venflon needle in the proximal and the distal stub of the tendon. Thereafter they will be randomized to three post-operative treatment regimes: Control, range of motion or immobilized From the currently available data (4, 5, 6) it is suggested that the brace is worn for 6 weeks after surgery in all three groups of the present experiment. The control group will be allowed partial weight-bearing from day 0 and full weight-bearing from week 4, toe rises after 16 weeks, jogging after 24 weeks and return to sports 34 weeks after. The two delayed weight-bearing groups (range motion group and immobilized group) will be restricted completely from weight-bearing initially (6 weeks), allowed partial weight-bearing after 6 weeks and full weight-bearing after 8 weeks.

Interventions

OTHERRange of motion

25 range of motion exercises of the ankle, 5 times per day.

OTHERDelayed weight-bearing

No weight-bearing during the first six weeks, and partial weight-bearing during the two following weeks

Sponsors

University of Copenhagen
CollaboratorOTHER
Danish Council for Independent Research
CollaboratorOTHER
Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No

Inclusion criteria

* Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon * Presented within 14 days from injury

Exclusion criteria

* re-rupture * other injuries affecting their lower limb functions * systemic diseases influencing tendon healing * immunosuppressive treatment including systemic corticosteroid treatment * inability to follow rehabilitation or follow-ups.

Design outcomes

Primary

MeasureTime frameDescription
Tendon elongation2, 6, 12, 26 and 52 weeks after ruptureTendon elongation will be evaluated using x-ray and measurements of the distance between tantalum beads

Secondary

MeasureTime frameDescription
Achilles tendon total rupture score (ATRS)12, 26 and 52 weeks after rupturePatient reported outcome regarding function in their Achilles tendon
Elastic modulus of the tendon6, 26 and 52 weeks after ruptureTendon stiffness will be evaluated during a voluntary plantar flexion contraction where force and tendon elongation is measured using a force transducer and x-ray, respectively. Tendon size will be evaluated by MRI. Elastic modulus will be calculated based on stiffness and size of the tendon.
Range of motion test26 and 52 weeks after ruptureRange of motion in the ankle will be measured.
Heel-rise26 and 52 weeks after ruptureThe number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.
Plantar flexion muscle strength26 and 52 weeks after rupturePlantar flexion muscle strength will be measured during a maximal voluntary isometric contraction with ankle flexion at -10, 0˚ of dorsiflexion
Calf muscle size6, 26 and 52 weeks after ruptureCalf muscle size will be assessed using MRI.
Tendon size6, 26 and 52 weeks after ruptureTendon size will be assessed using MRI.
Victorian Institute of Sport Assessment questionnaire - Achilles tendinopathy (VISA-A)12, 26 and 52 weeks after rupturePatient reported outcome regarding pain in their Achilles tendon.

Countries

Denmark

Contacts

Primary ContactPernilla Eliasson, PhD
pernilla.eliasson@gmail.com+46739864982
Backup ContactAnne-Sofie Andersen, PT, MSc
a_sofie_a@hotmail.com+4535315059

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026