Outcome After Conservatively Treated Achilles Tendon Rupture

Condition(s) studied

Investigational drug(s) / intervention(s)

11 week restrictive regime: As part of standard care at AUH (until May 2024), patients are immobilized in scotch cast with the foot in plantarflexion during week 0-4. Next, the scotch cast is replaced by a ROM-WALKER in plantarflexion for the next 7 weeks (week 5-11 after injury). The ROM-WALKER is gradually corrected from 30 degrees plantarflexion to 0 degrees. No weight bearing or exercises is allowed and they are not allowed to remove the ROM-WALKER during week 0-10. At week 11, the patients are allowed weight bearing up to 30 kg, after which there is no longer weight bearing restrictions. From week 12 they are allowed full weight bearing with a 1 cm heel lift i their shoes.

8 week liberal regime: The patients are treated with a walker orthosis with 3 wedges in plantarflexion, during week 1-2 with no weight bearing and no exercises. After 2 weeks, the tendon will be examined, and if no defect in the tendon is detected by palpation, the patients will start partially weight bearing in week 3-5, and full weight-bearing week 6-8. They are instructed in unloaded exercises for the calf and anklejoint after 2 weeks, and loaded exercises (elastic) after 5 weeks, with a maximum position til 0 degrees in the anklejoint. Balancetraining and stationary bike training after 7 weeks. The wedges are removed one by one after 3, 5 and 7 weeks, respectively. If there is a palpable defect in the tendon after 2 weeks, the patient must wait 1 week with partially weight bearing and exercises, and remove the wedges at 4, 5 and 7 weeks after the initiation of treatment. From week 9, walking i their shoes with a 1 cm heel lift.

Study summary

The main purpose of the study is to compare the patient-reported outcomes and adverse events of two different rehabilitation regimes for patients undergoing non-surgical treatment of Achilles Tendon Rupture. Thus, using a pre-post study design we will compare whether patients participating in an 8-week liberal rehabilitation regime will achieve the same, or better, self- reported functional ability, without increased risk of adverse events, in the first two years following injury, compared to an 11 weeks more restrictive rehabilitation regime..

Eligibility

Primary outcome measure(s)

• Self-reported ATRS score at 12 months after injury — 12 months post-injury
  Achilles tendon Total Rupture Score (ATRS) is a self-reported questionnaire with 10 items, summing up to a score of 0-100 points, with 100 points reflecting no disability. The primary outcome will be ATRS score at 12 months, but data will also be collected at 6 and 24 months to describe any changes over time.

Trial sites (1)

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