Non-operative Treatment of Acute Achilles Tendon Rupture Using Dynamic Rehabilitation. Influence of Early Weight-bearing Compared With Non-weight-bearing
NCT ID: NCT01470833
Last Updated: 2013-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2011-04-30
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
There is no consensus concerning the best treatment of acute achilles tendon rupture. Traditionally, surgical treatment is considered superior, but more recent studies show evidence that non-operative treatment with early dynamic rehabilitation gives the same functional outcome with fewer side effects.
Traditionally non-operative treatment involves non-weightbearing for 6 weeks. This is not evidence based rather due to tradition. It is well documented that mechanical load improves tendon healing in general and has no detrimental effect on the healing of operated achilles tendons.
The objective of this randomized study is to compare early weight-bearing with non-weight-bearing following non-operative treatment of acutely ruptured Achilles tendons.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
There is no consensus on the best treatment of acute achilles tendon rupture. It is the authors' belief that the decision on non-operative or operative treatment significantly differ between the orthopedic surgical departments and individual orthopedic surgeons.
Surgery is traditionally considered superior to conservative treatment due to a lower risk of rerupture of the achilles tendon (4). Despite the fact that surgery has a significantly increased risk of serious side effects such as deep infection (4). The decision of operative treatment is based on studies comparing surgical treatment and early dynamisation with non-operative treatment without dynamisation. Recent studies show increasing evidence that non-operative treatment with early dynamisation of the ankle gives the same functional outcome as operative treatment without significantly increased risk of rerupture (5.6). The same studies show that the overall complication rate is higher with surgery than with non-operative treatment. The surgical complications include infection, nerve damage, adhesion, contracture and cosmetic problems.
Pajala et. al have compared outcome for patients who suffered rerupture with those who suffered a deep wound infection. They conclude that outcome after rerupture without complicating infection is satisfactory, whereas the outcome after deep wound infection is devastating (7). The risk of a debilitating complication is thus greater with surgery than is the case for conservative treatment.
Traditionally non-operative treatment involves non-weightbearing for 6 weeks. This is not evidence based rather due to tradition. Suchak et. al have shown that early weight bearing after surgical treatment of ASR improves health related quality of life in the period after surgery and has no negative effect on tendon healing.(9) It is well documented that mechanical load improves tendon healing (10). Thus it is reasonable to believe that early loading of the tendon under controlled conditions will affect tendon healing beneficially.
Objective of the study Primary purpose The objective of this randomized study is to compare early weight-bearing with non-weight-bearing following non-operative treatment of acutely ruptured Achilles tendons.
All patients are treated with dynamic rehabilitation in a DJO Walker orthosis. Functional outcome is self assessed using Achilles tendon Total Rupture Score (ATRS) and biomechanically by quantification of the stiffness of the achilles tendon and force development at concentric and eccentric work.
Secondary objectives Rerupture, time to return to work, time to return to sports.
Method and subjects:
The survey is conducted as a clinical randomized trial (RCT). Patients allowed to bear weight from day 1 are compared with patients who are not allowed to bear weight the first 6 weeks of treatment. The orthosis is equipped with a pressure sensor that detects when the patient bear weight on the foot. The project has been approved by the medical ethic committee.
Population 30 persons will be included in each group. Altogether 60 persons will be included.
Timeplan The study is planned for a period of 3 years. Recruitment of patients started 1st of April 2011 and is expected to be completed in 2012. The follow up period is 2 years.
Procedures In the emergency room an ankle orthosis (DJO Walker) is applied with the foot in 30 degree plantar flexion. The orthosis is worn for 8 weeks gradually bringing the foot to 0 degrees. From day 15 dynamisation of the ankle joint is performed.
Treatment Week 1 to 2 3 wedges. The orthosis must be worn 24 hours a day. Can not be removed by bathing or at night.
Week 3 to 4 2 wedges. Dynamic rehabilitation. The boot can not be removed at night.
Week 5 to 6 1 wedge. Dynamic rehabilitation. The boot can not be removed at night.
Week 7 to 8 No wedges. Dynamic rehabilitation. The boot can be removed at night.
The group allowed early weight-bearing is instructed as follows:
Week 1 to 2 Weightbearing is allowed with in pain limit. Crutches are recommended.
Week 3 to 4 Full weightbearing is allowed. Week 5 to 8 Full weightbearing is allowed. Crutches should be avoided.
The group of non-weightbearing is instructed as follows:
Week 1 to 6 No weightbearing. Crutches are obligatory. Week 7 to 8 Full weightbearing is allowed.
Dynamic rehabilitation From day 15 patients of both groups must do ankle exercises. Minimum 5 times a day the patient must take of the orthosis. Sitting at a table with the leg hanging freely over the edge a series of 25 active dorsal flexion and passive plantar flexion exercises must be made.
Verification of compliance All DJO walkers used in the study are equipped with an integrated pressure sensor that detects when load is applied in the boot.
Rehabilitation After 8 weeks the patient is seen at the out patient clinic. They are instructed rehabilitation regime by a physiotherapist. Rehabilitation is designed as a home exercise program with emphasis on movement, stability, coordination and strength.
Week 9 to 16 The patient may cycle and swim. Week 16 to 26 Jogging on soft surfaces. Week 26 Sports can be resumed. We do not recommend badminton, tennis and squash as well as contact sports before week 40 - 52. Week 52 No restrictions
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-weight-bearing
The group of non-weightbearing is instructed as follows:
Week 1 to 6 No weightbearing. Crutches are obligatory. Week 7 to 8 Full weightbearing is allowed.
Dynamic rehabilitation From day 15 patients of both groups must do ankle exercises. Minimum 5 times a day the patient must take of the orthosis. Sitting at a table with the leg hanging freely over the edge a series of 25 active dorsal flexion and passive plantar flexion exercises must be made.
No interventions assigned to this group
Early weight-bearing
The group allowed early weight-bearing is instructed as follows:
Week 1 to 2 Weightbearing is allowed with in pain limit. Crutches are recommended.
Week 3 to 4 Full weightbearing is allowed. Week 5 to 8 Full weightbearing is allowed. Crutches should be avoided.
Early weight-bearing
The group allowed early weight-bearing is instructed as follows:
Week 1 to 2 Weight-bearing is allowed with in pain limit. Crutches are recommended.
Week 3 to 4 Full weight-bearing is allowed. Week 5 to 8 Full weight-bearing is allowed. Crutches should be avoided.
Dynamic rehabilitation From day 15 patients of both groups must do ankle exercises. Minimum 5 times a day the patient must take of the orthosis. Sitting at a table with the leg hanging freely over the edge a series of 25 active dorsal flexion and passive plantar flexion exercises must be made.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Early weight-bearing
The group allowed early weight-bearing is instructed as follows:
Week 1 to 2 Weight-bearing is allowed with in pain limit. Crutches are recommended.
Week 3 to 4 Full weight-bearing is allowed. Week 5 to 8 Full weight-bearing is allowed. Crutches should be avoided.
Dynamic rehabilitation From day 15 patients of both groups must do ankle exercises. Minimum 5 times a day the patient must take of the orthosis. Sitting at a table with the leg hanging freely over the edge a series of 25 active dorsal flexion and passive plantar flexion exercises must be made.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The patient must be able to speak and understand Danish.
* The patient must be able to give informed consent.
* The patient should be able to follow a regimen with a removable ankle orthosis.
* The patient must be able to determine when rupture occurred, and it can't be over 4 days old.
* The patient should be able to follow the postoperative controls.
Exclusion Criteria
* Former achilles tendon rupture
* Former surgery on the achilles tendon
* Treatment with fluoroquinolones during the last 6 months.
* Tendinosis treated with a tablet or injection with corticosteroids within the last 6 months.
* Diagnosis of arterial insufficient in the leg.
* Lack of palpable pulse in the foot
* Severe medical illness: ASA score greater than 2
* Distance from calcaneus to the rupture is less than 1 cm
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DJO Incorporated
INDUSTRY
Hvidovre University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kristoffer Barfod
Medical Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kristoffer W Barfod, Medical Doctor
Role: STUDY_CHAIR
Hvidovre University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hvidovre Hospital
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASR2011
Identifier Type: -
Identifier Source: org_study_id