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Healing of Human Achilles Tendon Rupture

Primary Purpose

Achilles Tendon Rupture

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Range of motion
Delayed weight-bearing
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Rehabilitation, Weight-bearing, Range of motion

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

Range of motion

Immobilization

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Tendon elongation
Tendon elongation will be evaluated using x-ray and measurements of the distance between tantalum beads

Secondary Outcome Measures

Heel-rise
The number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.
Achilles tendon total rupture score (ATRS)
Patient reported outcome regarding function in their Achilles tendon
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.
Range of motion test
Range of motion in the ankle will be measured.
Victorian Institute of Sport Assessment questionnaire - Achilles tendinopathy (VISA-A)
Patient reported outcome regarding pain in their Achilles tendon.
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
Calf muscle size
Calf muscle size will be assessed using MRI.
Tendon size
Tendon size will be assessed using MRI.

Full Information

First Posted
April 16, 2015
Last Updated
April 20, 2015
Sponsor
Bispebjerg Hospital
Collaborators
University of Copenhagen, Danish Council for Independent Research
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1. Study Identification

Unique Protocol Identification Number
NCT02422004
Brief Title
Healing of Human Achilles Tendon Rupture
Official Title
Healing of Human Achilles Tendon Rupture: Loading Pattern After Surgical Repair to Achieve Optimal Mechanical Properties and Clinical Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
University of Copenhagen, Danish Council for Independent Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
Rehabilitation, Weight-bearing, Range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Range of motion
Arm Type
Experimental
Arm Description
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.
Arm Title
Immobilization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Range of motion
Intervention Description
25 range of motion exercises of the ankle, 5 times per day.
Intervention Type
Other
Intervention Name(s)
Delayed weight-bearing
Intervention Description
No weight-bearing during the first six weeks, and partial weight-bearing during the two following weeks
Primary Outcome Measure Information:
Title
Tendon elongation
Description
Tendon elongation will be evaluated using x-ray and measurements of the distance between tantalum beads
Time Frame
2, 6, 12, 26 and 52 weeks after rupture
Secondary Outcome Measure Information:
Title
Heel-rise
Description
The number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.
Time Frame
26 and 52 weeks after rupture
Title
Achilles tendon total rupture score (ATRS)
Description
Patient reported outcome regarding function in their Achilles tendon
Time Frame
12, 26 and 52 weeks after rupture
Title
Elastic modulus of the tendon
Description
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.
Time Frame
6, 26 and 52 weeks after rupture
Title
Range of motion test
Description
Range of motion in the ankle will be measured.
Time Frame
26 and 52 weeks after rupture
Title
Victorian Institute of Sport Assessment questionnaire - Achilles tendinopathy (VISA-A)
Description
Patient reported outcome regarding pain in their Achilles tendon.
Time Frame
12, 26 and 52 weeks after rupture
Title
Plantar flexion muscle strength
Description
Plantar flexion muscle strength will be measured during a maximal voluntary isometric contraction with ankle flexion at -10, 0˚ of dorsiflexion
Time Frame
26 and 52 weeks after rupture
Title
Calf muscle size
Description
Calf muscle size will be assessed using MRI.
Time Frame
6, 26 and 52 weeks after rupture
Title
Tendon size
Description
Tendon size will be assessed using MRI.
Time Frame
6, 26 and 52 weeks after rupture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pernilla Eliasson, PhD
Phone
+46739864982
Email
pernilla.eliasson@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sofie Andersen, PT, MSc
Phone
+4535315059
Email
a_sofie_a@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Magnusson, PT, DSc, PhD
Organizational Affiliation
Bispebjerg Hospital, University of Copenhagen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Kjaer, MD, PhD
Organizational Affiliation
Bispebjerg Hospital, University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sofie Andersen, PT, MSc
Phone
+4535315059
Email
a_sofie_a@hotmail.com
First Name & Middle Initial & Last Name & Degree
Christian Couppé, PT, MSc, PhD
Phone
+4535316091
Email
ccouppe@gmail.com
First Name & Middle Initial & Last Name & Degree
Pernilla Eliasson, MSc, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17855761
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. doi: 10.1113/jphysiol.2007.139105. Epub 2007 Sep 13.
Results Reference
background
PubMed Identifier
10512344
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. doi: 10.1097/00042752-199907000-00007.
Results Reference
background
PubMed Identifier
21106412
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.
Results Reference
background
PubMed Identifier
19541735
Citation
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.
Results Reference
background
PubMed Identifier
10428130
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. doi: 10.2106/00004623-199907000-00011.
Results Reference
background
PubMed Identifier
16973901
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. doi: 10.1177/0363546506293255. Epub 2006 Sep 14.
Results Reference
background
PubMed Identifier
29965789
Citation
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.
Results Reference
derived

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Healing of Human Achilles Tendon Rupture

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