MedTrace Logo

Outcome After Conservatively Treated Achilles Tendon Rupture

NCT05614908 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2024-09-20

No results posted yet for this 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..

Conditions

  • Achilles Tendon Rupture
  • Achilles Tendon Injury

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Nanna Rolving, Ph.d. · Aarhus University Hospital, Department of physiotherapy and occupational therapy

  • Per Gundtoft, Ph.d. · Aarhus University Hospital, Department of Orthopaedics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2028-02-01
Completion
2028-02-01

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614908 on ClinicalTrials.gov