Surgical repair Achilles tendon rupture and Non-surgical repair Achilles tendon rupture in Achilles Tendon Rupture - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Achilles Tendon Rupture

Intervention / Treatment

Detailed Description

Methodology This study is a multi-centre prospective randomized controlled clinical trial. This study will be conducted at five tertiary care centres by orthopaedic surgeons with an interest in soft tissue trauma. All subjects will be recruited over a one year period. Subjects who meet the following inclusion and exclusion criteria and who consent to involvement in the study will be randomized to either operative or non-operative arms of the study. All patients who enter the study will receive a pre-treatment ultrasound to document that the tear is complete and to document the location of the tear. Prior to obtaining consent for the study the risks and benefits of each treatment option will be clearly explained along with the current state of knowledge concerning treatment of Achilles tendon ruptures. It will be explained to each study participant that involvement in the study is voluntary and that they are free to discontinue their involvement at any point in their treatment .

Inclusion Criteria

Complete Achilles Tendon Rupture
Less than 7 days from date of injury
Age 18-70 years of age
Ability to follow rehab protocol

Exclusion Criteria

Inability to Speak English
Significant ipsilateral injury
Open injury to Achilles tendon
Neurological disease (ie stroke, cerebral palsy)
Collagen Disease (ie Ehlers Danlos disease)
Pregnancy
Fluoroquinolone associated rupture (rupture within 2 weeks of taking medication)
Unfit for surgery
Diabetes
Peripheral Vascular disease
Avulsion of Achilles tendon from calcaneus

Surgical Repair If randomized to the operative group, all patients will be evaluated and informed consent obtained. Surgery will performed as outpatient day surgery. Prophylactic antibiotics will be given one hour prior to the procedure. All patients will receive general anaesthesia and endotracheal intubation. The patient will be positioned prone on bolsters on the operative table. A tourniquet will be applied to the thigh of the affected extremity and inflated to 300 mmHg at the start of the case.

The affected limb will be prepared and draped in the standard fashion. A medial to lateral curvilinear incision will be utilzed. The posterior aspect of the tendon and tendon sheath will then be exposed. Evacuation of the overlying clot will then expose the ruptured tendon. Two ethibond sutures will be placed in each end of the torn tendon (total of four sutures). Two ethibond sutures will be placed in a modified Bunnel stitch fashion entering at the tear site, first going proximally towards normal tendon and then distally towards the calcaneus. With the foot in neutral alignment the sutures will be tied proximally and distally in normal tendon away from the tear site. A 2-0 vicryl suture will then be place at the site of the repair in a running fashion to augment the repair. The wound will be irrigated and the tendon sheath will be closed with a running 2-0 running vicryl stitch. The skin will be closed with interrupted 3-0 nylon suture and a sterile dressing and tubigrip applied.

In the recovery room the patient will be fitted with a plaster backslab in gravity plantar flexion (approx. 20 degrees).

Postoperative Protocol Patients will be instructed to be non-weight bearing on their injured side with crutch assistance until seen in the outpatient clinic in 7-10 days. Patients will then be fitted for and Air Cast Boot splint. Patients will then be instructed to be weight bearing as tolerated on their injured side with crutch assistance for a period of six weeks.

Patients will be allowed active plantar flexion and dorsiflexion up to neutral with physiotherapy supervision. The Air Cast Boot will be removed for therapy but should be worn otherwise for protection. At six weeks patients will have their splints removed and be allowed to weight bear as tolerated. At the six week interval patients will also begin to perform dorsiflexion stretching exercises and will begin graduated resistance exercises. Follow up appointments will be 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery.

Functional Bracing Treatment If randomized to the functional bracing group, subjects will have an Air Cast Boot splint applied with a 2cm felt heel lift. Ath two weeks the heel lift will be removed. As with the operative group patients will be weight bearing as tolerated on their injured side with crutch assistance for six weeks. Similarly, subjects will be allowed to remove the Air Cast Boot and perform active plantar flexion and dorsiflexion up to neutral with physiotherapy supervision. At six weeks the patients will have their Cast Boots removed and dorsiflexion stretching exercises will be begun. A gentle resistance program will also begin at six weeks along with dorsiflexion stretching exercises. Follow up appointments will be 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following the initial injury.

Re-rupture Rate and Complications The primary outcome measure will be re-rupture rate. This will be determined at follow-up intervals of: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years

Re-rupture rates between the operative and non-operative groups will be calculated and statistically analysed using a student's t test. P values of less than 0.05 will be considered significant. Any clinical suspicion of a re-rupture will require an ultrasound for confirmation. Re-ruptures will be treated surgically. At the above listed follow-up intervals other complications will also be recorded including:

Minor complications

superficial infection
wound hematoma
delayed wound healing
scar adhesion
sensory disturbances
suture granuloma

Major Complications

re-rupture
equinus postioning of foot
extreme lengthening of tendon
deep infection
chronic fistula
necrosis of skin
deep vein thrombosis
embolism
death

Range of Motion, Strength and Calf Circumference Range of motion and calf circumference will be documented at 6 weeks, 3 months, 6 months, 1 year and 2 years. Active range of motion only will be recorded to avoid healing setbacks. Calf circumference will be recorded and compared to the unaffected extremity.

Strength Testing Strength testing will be performed on all study participants. This will be done at follow-up visits at 6 months, 1 year and 2 years. These measurements will include peak torque and total work. A cybex dynamometer will be used to test isokinetic concentric plantar and dorsiflexion strength at 30, 90 and 240 degrees per second. All values will be compared to the opposite unaffected side. Scores will then be transformed into a percentage of the unaffected side and points awarded appropriately as per the outcome measure designed by Leppilahti et al.

Disease Specific Quality of Life In the debate surrounding the most effective management of Achilles tendon ruptures, surgeons have argued about which individual factor signifies success. Many authors have suggested that re-rupture rate should be considered the measure of successful treatment, while others suggest minor complications or return to sport may also warrant consideration.

This study will utilize a previously published outcome scoring system that attempts to evaluate important factors in the recovery from this injury. This measurement tool published by Leppilahti et al utilizes a combination of factors including pain, stiffness and footwear restrictions as well as objective strength values, to arrive at an overall score. Statistical analysis using a students t test will be applied to the outcome score means of the operative and non-operative groups. P values of less than 0.05 will be considered significant. The application of this scoring system to a prospective randomized trial comparing operative and non-operative treatment of this condition will hopefully shed some much needed light on this therapeutic dilemma.

Study Type

Interventional

Enrollment

150

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - London, Ontario, Canada, N6A 3K7
    - Fowler Kennedy Sport Medicine Clinic, University of Western Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Complete Achilles Tendon Rupture Less than 7 days from date of injury Age 18-70 years of age Ability to follow rehab protocol

Exclusion Criteria:

Inability to Speak English Significant ipsilateral injury Open injury to Achilles tendon Neurological disease (ie stroke, cerebral palsy) Collagen Disease (ie Ehlers Danlos disease) Pregnancy Fluoroquinolone associated rupture (rupture within 2 weeks of taking medication) Unfit for surgery Diabetes Peripheral Vascular disease Avulsion of Achilles tendon from calcaneus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Re-rupture rate

Secondary Outcome Measures

Outcome Measure
Minor complications
Major Complications
Range of Motion, Strength and Calf Circumference
Strength Testing
Disease Specific Quality of Life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fowler Kennedy Sport Medicine Clinic

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

Principal Investigator: Kevin Willits, MD, The University of Western Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Willits K, Amendola A, Bryant D, Mohtadi NG, Giffin JR, Fowler P, Kean CO, Kirkley A. Operative versus nonoperative treatment of acute Achilles tendon ruptures: a multicenter randomized trial using accelerated functional rehabilitation. J Bone Joint Surg Am. 2010 Dec 1;92(17):2767-75. doi: 10.2106/JBJS.I.01401. Epub 2010 Oct 29.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria