Outcome After Conservatively Treated Achilles Tendon Rupture

Achilles Tendon Rupture Clinical Trial

Official title:

Patient-reported Outcomes After Non-operative Treatment of Acute Achilles Tendon Rupture: a Prospective Cohort Study.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05614908
• Other study ID #: AarhusUH-MFenger
• Status: Enrolling by invitation
• Start date: November 1, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: July 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main purpose of the study is to investigate self-reported functional ability of patients undergoing conservatively treated achilles tendon rupture at 6, 12 and 24 months from the date of injury.

Description:

Background:

The achilles tendon is the most injured tendon in the lower extremity. An achilles tendon rupture (ATR) is treated either surgically or non-surgically. Previous studies have investigated early controlled motion and weight-bearing for non-surgically treated ATR. Early motion may cause tendon elongation, which leads to decrease in push off strength, and thus potentially a poorer functional outcome. Conversely, delayed initiation of mobilisation and weight-bearing may similarly hinder or delay optimal recovery of function and return to work and sports. The correct treatment and rehabilitation, including the timing of rehabilitation initiation, may therefore be crucial to ensure the patients' functional ability.

Most hospitals in Denmark treating patients with ATR, provide a regime of 8 weeks immobilization for conservatively treated patients with ATR. At Aarhus University Hospital (AUH), however, a more restrictive regime is provided for these patients, requiring immobilization for 11 weeks after injury. Typically, a late initiation of mobilization is defined as mobilization beginning in week 8, i.e. 3 weeks sooner than the standard regime at AUH. Furthermore, many "late" mobilization regimes allows for some non-weightbearing exercises prior to week 8, but at AUH patients are recommended to limit any movement during the first 11 weeks after injury. This is primarily to reduce the risk of a re-rupture, the rate of which is lower at AUH than on a national level (i.e. <5% versus 7-8% re-rupture rate). However, this delayed onset of mobilization and weight-bearing may have a negative effect on return to normal function, sports and work.

Since 2012, a number of Danish hospitals, treating patients with ATR, have reported re-rupture rates, and self-reported functional ability and working status, etc. is reported at 6, 12 and 24 months. This data are published in a report, enabling comparison with other populations. At present, AUH does not report these data into to the database, and the data published in the early report may therefore serve as comparison group in this quality assurance study.

Purpose: The aim of this quality assurance study is therefore to investigate to what extent the stricter regime at AUH following conservatively treated ATR affects the patients' functional ability after 6, 12 and 24 months after injury, compared to patients treated at other Danish hospitals with less strict regimes.

Materials and methods:

Study design and participants:This is a cohort study, using self-reported data collected prospectively from approximately 100 consecutive patients (18+) recruited at AUH with a non-surgically treated ATR. These data will be compared with self-reported data from the Danish Achilles tendon Database (DAB) i.e. an existing cohort of patients with ATR treated at other Danish Hospitals. The data is freely available in yearly reports at (https://www.hvidovrehospital.dk/sorc-c/projects/Pages/The-Danish-Achilles-tendon-Database-(D ADB).aspx).

Standard mobilization procedure: As part of standard care at AUH, all patients treated non-surgically for ATR are immobilized in scotch cast during weeks 0-4. Next, the scotch cast is replaced by a ROM-WALKER for the next 7 weeks (week 5-11 after injury), but without weight bearing weeks 5-10. At week 11 the patients are allowed weight bearing up to 30 kg, after which there is no longer weight bearing restrictions.

Data collection: Patients will receive a digital letter with a link to an online questionnaire to be completed at 6 months, 12 months and 24 months from the date of injury.

Patients are asked to fill out the patient-reported outcome measure Achilles tendon Total Rupture Score, as well as additional questions regarding job status, return to sport, incidence of deep venous thrombosis, if they have had a re-rupture of the same achilles tendon and their satisfaction with treatment they received at the hospital.

The ATRS is a 10-item questionnaire, with a score of 0 to 10 (worst-best), which has been found valid, reliable and responsive in this population.

Statistical analysis:

The primary outcome is ATRS score at 12 months, which will be compared to the 12 month ATRS score in the 2021 report of the Danish Achilles Tendon Database (DADB), including app. 2000 patients.

The needed sample size to find a minimal clinical important difference of 10 points (SD 18) between our population and the population of DADB is 51 patients in each group, to achieve a power of 80% and alpha set at 5%.

Expected outcomes and perspectives: this study will bring knowledge about patient-reported outcomes on achilles function, physical acitivity and work status in patients with conservatively treated ATR, following an immobilization protocol of 11 weeks duration.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with an acute achilles tendon rupture treated conservatively at AUH

• 18 years or older

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Achilles Tendon Injury
• Achilles Tendon Rupture
• Rupture
• Tendon Injuries

Intervention

Other:
• 11 weeks of immobilization
Patients wear a scotch cast for the first 4 weeks. After that they are provided with a ROM-WALKER to be worn for the next 7 weeks, during which the ROM-walker is slowly moved from 30 degrees of plantarflexion up to 0 degrees. During the first 10 weeks, patients are not allowed any weight-bearing on the injured leg. From week 11 they are allowed 30 kg of weight-bearing in the ROM WALKER, and from week 12 full weight-bearing with a 1 cm heel lift in their shoes.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported functional ability at 12 months after injury	Achilles tendon Total Rupture Score 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	Percentage of participants who have returned to previous working status at 12 months	Self-reported return to previous work (if at working age)	12 months post-injury
Secondary	Percentage of participants who have returned to previous sports activities at 24 months	Self-reported return to sport	24 months post-injury
Secondary	Percentage of participants with re-rupture at 12 months	Self-reported re-rupture	12 months post-injury