Treatment Results After Acute Rupture of the Achilles Tendon.
Condition: Rupture of Achilles Tendon
MeSH terms: Rupture
Study type: Interventional

Summary: 
      To compare the end-results of three different methods of treatment of acute achilles tendon
      ruptures, it is necessary to establish identical rehabilitation protocols. Traditionally,
      early mobilization has been reserved for patients treated surgically and this may have
      unintentionally skewed treatment results. The investigators have therefore designed a
      prospective randomized trial performed as collaboration between Akershus University Hospital
      (Ahus), Oslo University Hospital (The Emergency Department), Østfold Hospital (Fredrikstad)
      and Drammen Hospital. The four institutions were chosen because of their geographical
      proximity and because they jointly have a substantial catchment area. Treatment is divided
      into three arms, and patients between 18 and 60 years of age sustaining first time achilles
      tendon ruptures will be invited to participate.
    

Detailed description: 
      Patients are randomized to either surgery or non-operative treatment. Surgery will be
      performed by open technique or by using a mini-invasive approach. Open surgery remains
      widespread and arguably the best documented treatment, however mini-invasive surgery is also
      included because of its potential to lessen the risk of wound complications. Michael Amlang
      and Hans Zwipp at the University of Dresden represent some of the leading foot- and ankle
      surgeons in Europe. They and their co-workers have developed a protocol for mini-invasive
      surgery using specially adapted proprietary instruments. Michael Amlang visited Ahus in 2012
      teaching the general principles of the Dresden mini-invasive treatment. To ensure optimal and
      reproducible results, surgeons participating in the study must master both techniques.

      All patients included in the study will be immobilized in equinus position for the first two
      weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a
      brace maintaining ∼12° plantar flexion (three heel lifts). We have chosen to use standardized
      heel lifts because it eases weightbearing compared to a hinged brace. After two weeks (four
      weeks from injury) the ankle position is adjusted to ∼8° plantar flexion (two heel lifts) and
      following additional two weeks the ankle position is adjusted to ∼4° plantar flexion (one
      heel lift). The last week of the orthosis treatment the heel lift is completely removed.
      Hence, the brace is retained for a total of six weeks, and patients are allowed full weight
      bearing as tolerated during the entire time period. The brace is worn day and night for the
      first two weeks, but is removed during nighttime for the last four weeks. Importantly, the
      immobilization regimen is identical for all three-treatment groups. To ensure identical
      rehabilitation following immobilization, physical therapy has to adhere to a standardized
      protocol supervised by an experienced physiotherapist at the Norwegian Sport Medicine Clinic
      (NIMI).

      The defined endpoint is treatment results evaluated by the Achilles tendon Total Rupture
      Score (ATRS). This is a patient-centered self-reporting instrument with good reliability,
      validity and sensitivity. Furthermore, ATRS will be combined with SF36, another commonly used
      self-reporting instrument. Pain is evaluated by a visual analogue scale (VAS). Functional
      results are evaluated by The MuscleLab measurement system (Ergotest Innovation, Porsgrunn,
      Norway). The system consists of two different jump tests (drop counter-movement jump and
      hopping), two different strength tests (concentric heel rise and eccentric-concentric heel
      rise) and one muscular endurance test (standing heel rise) and the system has been shown to
      be both valid and reliable assessing lower leg function in patients with Achilles
      tendinopathy. We will also measure dorsiflexion and plantarflexion range of movement (ROM) as
      well as the circumference of the calf, all widely used endpoints in similar studies.
      Secondly, we want to compare the risk of complications such as infections and reruptures. The
      patients are examined at baseline and after 6 and 12 months. Since there are only minor
      functional improvements after 12 months, we do not plan any later follow-up as part of the
      main project. The 6 and 12 months examinations will be completed at the Norwegian Sport
      Medicine Clinic (NIMI), these examinations are blinded and performed by two physiotherapists
      who have not been taking part in the study prior to final follow-up. Patients will be wearing
      knee socks to hide potential scar tissue.

      Although the minimum clinically important difference in ATRS score has yet to be determined,
      Carmont and coworkers have shown that 7 points represent the smallest detectable change.
      Moreover, a study by Metz et al. found that patients with reruptures of the achilles tendon
      presented on average 18 points lower scores whereas patients with injuries of the sural nerve
      or superficial wound infections presented scores 10 and 9 points lower than average,
      respectively. In order to detect a difference of 7 points in ATRS score with 80% power there
      must be 160 patients in each group. Power calculations are based on one-way ANOVA analyses
      assuming a common standard deviation of 20. This concomitantly allows us to detect
      differences as low as 8 % with respect to complications. This is of pivotal importance since
      assessing the risk of reruptures is essential when establishing treatment recommendations. We
      therefore plan to include a total of 530 patients allowing for expected loss during
      follow-up. Ahus, The Emergency Department of Oslo University Hospital, Drammen and
      Fredrikstad Hospitals have a catchment area of nearly 1.3 million people and treats in excess
      of 300 achilles tendon ruptures annually. This allows for completion of the inclusion period
      within three years. In our view, this is the first study to include a sufficient number of
      patients to detect lesser, but yet important differences, and the results will be published
      in a suitable international peer-reviewed journal.

      The prospective randomized trial embodies many different disciplines and will spur off
      follow-up studies. As part of the main project we will conduct a treatment-cost analysis in
      relation to individual results. We will also perform an investigation based on ultrasound
      grading of Achilles tendon ruptures according to a classification system established by
      Michael Amlang and colleagues. Previous studies have provided evidence suggesting that
      treatment results may depend on the extension of the injury, and that treatment
      recommendations should be based on type of rupture sustained. This is of particular interest
      as it may facilitate individualized treatment. Together with the prospective randomized trial
      and the treatment-cost analysis, the ultrasound investigation will constitute the core of the
      Doctor of Philosophy (PhD) project.
    

Intervention name(s): Non-operative treatment; Open surgery; Mini-invasive surgery
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none. Patients randomized to non-operative treatment will have a cast applied within 3 days from injury.; All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none.; We will use the technique developed by Dr. Amlang and Professor Zwipp from Dresden, Germany. They have developed a protocol of mini-invasive surgery using specially adapted proprietary instruments.
All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Achilles; Tendon; Rupture; Acute; Treatment; Outcome measure