Healing of Human Achilles Tendon Rupture

Achilles Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02422004
• Other study ID #: BBH100
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2015
• Last updated: April 20, 2015
• Start date: August 2012
• Est. completion date: September 2016

Study information

• Verified date: April 2015
• Source: Bispebjerg Hospital
• Contact: Pernilla Eliasson, PhD
• Phone: +46739864982
• Email: pernilla.eliasson[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Other:
• Range of motion
25 range of motion exercises of the ankle, 5 times per day.
• Delayed weight-bearing
No weight-bearing during the first six weeks, and partial weight-bearing during the two following weeks

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Danish Council for Independent Research, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

Andersson T, Eliasson P, Aspenberg P. Tissue memory in healing tendons: short loading episodes stimulate healing. J Appl Physiol (1985). 2009 Aug;107(2):417-21. doi: 10.1152/japplphysiol.00414.2009. Epub 2009 Jun 18. — View Citation

Kangas J, Pajala A, Ohtonen P, Leppilahti J. Achilles tendon elongation after rupture repair: a randomized comparison of 2 postoperative regimens. Am J Sports Med. 2007 Jan;35(1):59-64. Epub 2006 Sep 14. — View Citation

Maffulli N, Waterston SW, Squair J, Reaper J, Douglas AS. Changing incidence of Achilles tendon rupture in Scotland: a 15-year study. Clin J Sport Med. 1999 Jul;9(3):157-60. — View Citation

Magnusson SP, Narici MV, Maganaris CN, Kjaer M. Human tendon behaviour and adaptation, in vivo. J Physiol. 2008 Jan 1;586(1):71-81. Epub 2007 Sep 13. Review. — View Citation

Mortensen HM, Skov O, Jensen PE. Early motion of the ankle after operative treatment of a rupture of the Achilles tendon. A prospective, randomized clinical and radiographic study. J Bone Joint Surg Am. 1999 Jul;81(7):983-90. — View Citation

Saxena A, Ewen B, Maffulli N. Rehabilitation of the operated achilles tendon: parameters for predicting return to activity. J Foot Ankle Surg. 2011 Jan-Feb;50(1):37-40. doi: 10.1053/j.jfas.2010.10.008. Epub 2010 Nov 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tendon elongation	Tendon elongation will be evaluated using x-ray and measurements of the distance between tantalum beads	2, 6, 12, 26 and 52 weeks after rupture	No
Secondary	Heel-rise	The number of heel-rises and the heel-rise height will be used for; calculation of the heel-rise work.	26 and 52 weeks after rupture	No
Secondary	Achilles tendon total rupture score (ATRS)	Patient reported outcome regarding function in their Achilles tendon	12, 26 and 52 weeks after rupture	No
Secondary	Elastic modulus of the tendon	Tendon 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.	6, 26 and 52 weeks after rupture	No
Secondary	Range of motion test	Range of motion in the ankle will be measured.	26 and 52 weeks after rupture	No
Secondary	Victorian Institute of Sport Assessment questionnaire - Achilles tendinopathy (VISA-A)	Patient reported outcome regarding pain in their Achilles tendon.	12, 26 and 52 weeks after rupture	No
Secondary	Plantar flexion muscle strength	Plantar flexion muscle strength will be measured during a maximal voluntary isometric contraction with ankle flexion at -10, 0° of dorsiflexion	26 and 52 weeks after rupture	No
Secondary	Calf muscle size	Calf muscle size will be assessed using MRI.	6, 26 and 52 weeks after rupture	No
Secondary	Tendon size	Tendon size will be assessed using MRI.	6, 26 and 52 weeks after rupture	No