This study is intended to determine whether the optimal treatment of acute Achilles
tendon ruptures is surgical repair or functional bracing.

Our hypotheses are surgical repair will: 1) Result in a clinically relevant decrease in
re-rupture rate and 2) Result in a clinically relevant improvement in disease specific
quality of life and 3) A clinically relevant improvement in functional outcome measures

Operative Versus Non-operative Treatment of Achilles Tendon Rupture

Achilles Tendon Rupture

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.

Operative Versus Non-operative Treatment of Achilles Tendon Rupture

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status