Clinical Trial: Treatment Results After Acute Rupture of the Achilles Tendon.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Non-operative Treatment of Acute Achilles Tendon Ruptures Versus Open and Mini-invasive Surgery: A Prospective Randomized Trial.

Brief 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 Summary:

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 t
Sponsor: University Hospital, Akershus

Current Primary Outcome: The defined endpoint is treatment results evaluated by the Achilles tendon Total Rupture Score (ATRS) at 12 month follow-up examination. [ Time Frame: The patients are examined at baseline and after 6 and 12 months. ]

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). 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Risk of complications such as infections and reruptures within 12 months after initiation of treatment. [ Time Frame: The patients are examined at baseline and after 6 and 12 months. ]

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.


Original Secondary Outcome: Same as current

Information By: University Hospital, Akershus

Dates:
Date Received: January 28, 2013
Date Started: February 2013
Date Completion: December 2018
Last Updated: January 25, 2017
Last Verified: January 2017