Healing of Human Achilles Tendon Rupture

NCT ID: NCT02422004

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-09-30

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.

Conditions

Achilles Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

This constitutes the currently accepted regime and is therefore consider the control group (CTRL) with early range of motion and early weight bearing. The control group was allowed to have partial weight-bearing from day 0 and full weight-bearing from week 4. Furthermore, they were instructed in tendon strain exercise identical with the range of motion group.

Group Type: ACTIVE_COMPARATOR

Range of motion

Intervention Type: OTHER

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

Range of motion

Early range of motion and delayed weight bearing (ROM). The range of motion group was restricted completely from weight-bearing until week 6, allowed partial weight-bearing after 6 weeks and full weight-bearing after 8 weeks. In addition to this, the patients were instructed to perform tendon strain exercises, five times a day, from week 2. The exercises were performed by removing the foot from the brace and then perform light dorsal ankle movement, 25 repetitions/time, when sitting on a table.

Group Type: EXPERIMENTAL

Range of motion

Intervention Type: OTHER

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

Delayed weight-bearing

Intervention Type: OTHER

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

Immobilization

Delayed weight-bearing or range of motion (IMMOB). The immobilization group was restricted completely from weight-bearing until week 6, allowed partial weight-bearing after 6 weeks and full weight-bearing after 8 weeks.

Group Type: EXPERIMENTAL

Delayed weight-bearing

Intervention Type: OTHER

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

Interventions

Range of motion

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

Intervention Type: OTHER

Delayed weight-bearing

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Danish Council for Independent Research

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pernilla Eliasson

Postdoc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Magnusson, PT, DSc, PhD

Role: STUDY_DIRECTOR

Bispebjerg Hospital, University of Copenhagen

Michael Kjaer, MD, PhD

Role: STUDY_DIRECTOR

Bispebjerg Hospital, University of Copenhagen

Locations

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Pernilla Eliasson, PhD

Role: CONTACT

pernilla.eliasson@gmail.com

+46739864982

Anne-Sofie Andersen, PT, MSc

Role: CONTACT

a_sofie_a@hotmail.com

+4535315059

Facility Contacts

Anne-Sofie Andersen, PT, MSc

Role: primary

a_sofie_a@hotmail.com

+4535315059

Christian Couppé, PT, MSc, PhD

Role: backup

ccouppe@gmail.com

+4535316091

References

Magnusson SP, Narici MV, Maganaris CN, Kjaer M. Human tendon behaviour and adaptation, in vivo. J Physiol. 2008 Jan 1;586(1):71-81. doi: 10.1113/jphysiol.2007.139105. Epub 2007 Sep 13.

Reference Type: BACKGROUND

PMID: 17855761 (View on PubMed)

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. doi: 10.1097/00042752-199907000-00007.

Reference Type: BACKGROUND

PMID: 10512344 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21106412 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19541735 (View on PubMed)

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. doi: 10.2106/00004623-199907000-00011.

Reference Type: BACKGROUND

PMID: 10428130 (View on PubMed)

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. doi: 10.1177/0363546506293255. Epub 2006 Sep 14.

Reference Type: BACKGROUND

PMID: 16973901 (View on PubMed)

Eliasson P, Agergaard AS, Couppe C, Svensson R, Hoeffner R, Warming S, Warming N, Holm C, Jensen MH, Krogsgaard M, Kjaer M, Magnusson SP. The Ruptured Achilles Tendon Elongates for 6 Months After Surgical Repair Regardless of Early or Late Weightbearing in Combination With Ankle Mobilization: A Randomized Clinical Trial. Am J Sports Med. 2018 Aug;46(10):2492-2502. doi: 10.1177/0363546518781826. Epub 2018 Jul 2.

Reference Type: DERIVED

PMID: 29965789 (View on PubMed)

Other Identifiers

BBH100

Identifier Type: -

Identifier Source: org_study_id