Outcome After Conservatively Treated Achilles Tendon Rupture

NCT05614908 | Enrolling By Invitation

• 1 other identifier: AarhusUH-MFenger
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Achilles tendon rupture; Functional ability; Immobilization

Outcome Measures

Primary Outcomes (1)

• Self-reported ATRS score at 12 months after 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.

  12 months post-injury

Secondary Outcomes (3)

• Percentage of participants with re-rupture at 12 months

  12 months post-injury

• Percentage of participants who have returned to previous working status at 12 months

  12 months post-injury

• Extend of participants who have returned to sports activities at 24 months

  24 months post-injury

Study Arms (1)

Patients with Achilles tendon rupture

Patients treated non-surgically at Aarhus University Hospital from 2022 to approximately 2028. Comparing an 8 week liberal regime wtih an 11 week restrictive regime.

Other: 11 week restrictive regime; Other: 8 week liberal regime

Interventions

11 week restrictive regime OTHER

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.

Patients with Achilles tendon rupture

8 week liberal regime OTHER

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.

Patients with Achilles tendon rupture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of approx. 220 consecutive acute achilles tendon rupture patients, treated non-surgically at Aarhus University Hospital from 2022 to approximately 2028.

You may qualify if:

• Patients with an acute achilles tendon rupture treated non-surgically at AUH
• Treatment start maximum 14 days after time of rupture
• ≥18 years
• Understand and read Danish

You may not qualify if:

• Patients who have not followed the regime at AUH (e.g. terminated use of the ROM- walker prematurely or similar)
• Bilateral ATR or rupture of the opposite in the treatmentperiod

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Study Officials

• Nanna Rolving, Ph.d.

  Aarhus University Hospital, Department of physiotherapy and occupational therapy

  STUDY DIRECTOR

• Per Gundtoft, Ph.d.

  Aarhus University Hospital, Department of Orthopaedics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 14, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)