Operative Versus Non-operative Treatment of Achilles Tendon Rupture
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      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
    

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.
    

Intervention name(s): Surgical repair Achilles tendon rupture; Non-surgical repair Achilles tendon rupture
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Achilles tendon; Rupture; Non-operative; Operative