Non-operative Treatment of Acute Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization
Condition: Achilles Tendon Rupture; Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis; Rupture
Study type: Interventional

Summary: 
      Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8
      affects the functional outcome and patient reported outcome after treatment of acute Achilles
      tendon rupture.

      Type of study

      Randomized, controlled trial (RCT). 130 patients will be included.

      Time schedule

      Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years

      Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are
      treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage
      is changed to a removable orthosis and full weight bearing is allowed.

      Patients who choose to participate in the trial will - through randomisation - be placed in
      one of the two groups:

        1. The intervention group: Must perform controlled mobilization-exercises from the
           beginning of week 3.

        2. The control group: In line with the current treatment regimen the patients must keep the
           boot on at all times and they are not allowed to move the ankle.

      Treatment protocol for the two groups is similar concerning orthose, removal of wedges and
      weight-bearing. The only difference is that patients in the intervention group are instructed
      to do ankle exercise.

      Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6 and 12
      months. The study's primary endpoint is at the 12 month mark.

      Population Patients who are treated for acute Achilles tendon rupture at Copenhagen
      University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to
      participate are treated according the standard regimen (non-operatively without early
      controlled movement of the ankle joint).

      Number of patients 65 patients will be included in each group (a 130 patients in total).
    

Detailed description: 
      Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8
      affects the functional outcome and patient reported outcome after treatment of acute Achilles
      tendon rupture.

      Study Design Type of study The study is performed as a single-blinded, randomized, controlled
      trial (RCT). The randomisation is computer based; opaque envelopes are used. In total 130
      patients will be included.

      Time schedule Recruitment of patients for the study begins 1st of November 2013. The expected
      study period is 4-5 years; the recruitment itself is expected to span 2 years, provided that
      an average of 6 patients is included per month.

      Method Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute
      ATR are treated non-operatively. A cast is applied in the emergency room. After 2 weeks the
      bandage is changed to a removable orthosis and full weight bearing is allowed.

      Patients who choose to participate in the trial will - through randomisation - be placed in
      one of the two groups:

        1. The intervention group: Must perform controlled mobilization-exercises from the
           beginning of week 3.

        2. The control group: In line with the current treatment regimen the patients must keep the
           boot on at all times and they are not allowed to move the ankle.

      Treatment protocol for the two groups is similar concerning orthose, removal of wedges and
      weight-bearing. The only difference is that patients in the intervention group are instructed
      to do ankle exercise.

      Compliance

      The following measures will be taken to ensure compliance within the groups:

        1. The intervention group: The patients will be equipped with training diaries in which
           they will record their training for each of the five daily training sessions.

        2. The control group: The orthosis will be sealed. If the boot is removed it can be
           registered.

           Blinding The doctors and physical therapists who will conduct the follow-up will be
           blinded to the intervention. This is ensured as a Project Nurse will be in charge of the
           randomisation. The patients will be given a direct phone number for the Project Nurse,
           as he/she will be in charge of treatment related question and enquiries during the
           intervention period. Potential medical queries will be discussed with one of the
           affiliated doctors.

           Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6
           and 12 months. The study's primary endpoint is at the 12 month mark.

           Population Patients who are treated for acute Achilles tendon rupture at Copenhagen
           University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish
           to participate are treated according the standard regimen (non-operatively without early
           controlled movement of the ankle joint).

           Number of patients 65 patients will be included in each group (a 130 patients in total).
           The sample size calculation is based on a clinical relevant difference of 10 point in
           ATRS, a standard deviation (SD) of 16 and power of 0.90 (two sided). In a previous
           material, with a fully comparable population, we found a SD of 16 points at the 1 year
           post-examination. 54 patients is required in each group; due to the risk of drop out 65
           patients will be included in each group.

           Inclusion criteria

             -  Age 18-70 years.

             -  The patient must be expected to be able to attend rehabilitation and
                post-examinations.

             -  The patient must be able to speak and understand Danish.

             -  The patient must be able to give informed consent. Exclusion criteria

             -  Former rupture of one or both Achilles tendon(s).

             -  Previous surgery on the Achilles tendon.

             -  Fluoroquinolone treatment within the last 6 months.

             -  Tendinosis treated with corticosteroids (tablets or injections) within the last 6
                months.

             -  The patient has been diagnosed with arterial insufficiency in the legs.

             -  Terminal illness or severe medical illness: ASA score higher than or equal to 3.

             -  The space between the rupture and the calcaneus is less than 1cm.

           Data Registration

           All relevant data is recorded in a specially designed database. The data registration
           will be reported to the Danish Data Protection Agency.

           Primary endpoint The primary endpoint is evaluated at 12 month.

           ATRS: Achilles tendon Total Rupture Score 25 A patient reported validation score
           developed to assess symptoms and physical activity after treatment for Achilles tendon
           rupture.

           Secondary endpoints

           Heel-rise work test: Endurance test where the patient stands on one leg and lifts the
           heel up and down until exhaustion. The number and the height of the heel-rises are
           counted and measured. The results are then compared to the weight of the patient and the
           total work is estimated. The MuscleLab ® (Ergo Test Technology, Oslo, Norway)
           measurement system is used 25.

           Single heel-rise test: The patient stands with the foot in neutral position. It is
           recorded whether the patient is able to make a single heel-rise on the injured leg. The
           heel-rise is acknowledged if the heel can be lifted at least 2 cm with stretched knee.
           The MuscleLab ® (Ergo Test Technology, Oslo, Norway) measurement system is used 26.

           Ultrasound: The length between the calcaneus and the distal tip of the medial head of
           the gastrocnemius muscle.

           Amlangs ultrasound classification 27.

           Cost effectiveness analysis: A cost effectiveness analysis will be performed comparing
           the two treatment protocols.

           DVT screening: Ultra sound for deep Vein Thrombosis (DVT) will be performed after 2 and
           8 weeks.

           Perimeter of calf: The perimeter of the calf is measured at the widest point on the
           injured side after 16 weeks. The distance from this point to lower edge of the patella
           is measured in centimeters. The distance is used to measure the perimeter on the healthy
           leg and for all subsequent measurements during the trial.

           Re-ruptur (RR): It is registered if the tendon re-ruptures during the trial period.

           Work: Hard physical labour involving heavy lifting, climbing stairs or climbing the
           ladder. E.g. bricklayer, paviour, carpenter, dustman, mailman.

           Moderate physical work that involves a lot of walking. E.g. salesperson, shop assistant,
           nurse.

           Light physical work which only involves light walking. E.g. office work

           Return to work: It is recorded how many days have passed before work is resumed
           part-time and full-time.

           Sport: Does the patient do sports? If yes, what kind, how many hours per week on average
           and at what level (professional, amateur, exerciser).

           Return to sport: It is recorded how many days have passed before sport activities are
           resumed and how many days have passed before sport activities reach a premorbid level.

           Health information: Former disease in or around the Achilles tendon, rheumatic disease,
           dominant leg.

           Other data: Age, Cpr.nr., other master data necessary to identify and call back the
           patient for post-examinations.

           The study is carried out in accordance with the principles of the Helsinki Declaration.

           Patients are covered by the patient insurance of Copenhagen University Hospital
           Hvidovre.

           The protocol as well as the patient information and declaration of consent must be
           approved by the National Committee on Health Research Ethics before inclusion of
           patients will begin.

           The project manager is responsible for informing the National Committee on Health
           Research Ethics of any critical adverse event and/or major changes of the protocol. All
           correspondence will be filed by the project manager.

           Declaration of consent All patients will receive verbal and written information
           concerning the study. The inclusion will take place after a declaration of consent has
           been obtained. It is the responsibility of the investigators to provide patients with
           comprehensive verbal and written information concerning the course of the study,
           purpose, potential risks and benefits.

           Statistics

           The two groups are described descriptively regarding demographic parameters as well as
           primary and secondary endpoints as described above in the paragraph "Data registration".
           Comparison of the primary and secondary outcomes of both groups is done by using
           relevant statistics according to the characteristics of the variables and if necessary
           the normal distribution. The change of the outcomes over a period of time is described
           within each group.

           The research group

           The study is carried out as collaboration between the research unit, Clinical
           Orthopaedic Research Hvidovre (www.corh.dk) and the Department of Physical- and
           Occupational Therapy, both at Copenhagen University Hospital Hvidovre.

           Data analysis and writing articles The data analysis and the drawing up of articles are
           done by the project manager and last-author. The project group is regularly involved in
           the process.

           Economic conditions

           The study is funded by the Department of Orthopaedic Surgery and the Department of
           Physiotherapy, Copenhagen University Hospital Hvidovre.

           The project group has independently initiated the study. Patients will not receive any
           fees for participation.

           Publication It is expected that the study will be published in an international,
           high-impact journal. We will furthermore seek to have the results presented at both
           national and international medical conventions. The results will also be published
           online and in other relevant media.
    

Intervention name(s): Controlled early mobilization
Intervention type(s): Procedure
Intervention description(s): 1. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 - 8.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Achilles tendon; Rupture; Rehabilitation; Dynamic rehabilitation