Achilles Tendon RuptureNCT02760784
Medium Term Outcome of Nonoperative Treatment After Achilles Tendon Rupture.
An observational study of Achilles Tendon Rupture, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
A total of 56 patients completed a previous study regarding non-operative treatment for acute achilles tendon rupture. This study consists of an additional follow up after 4-5 years depending on original date of injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Early weight bearing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who participated and completed the original study: Barfod, K.W., et al., Nonoperative dynamic treatment of acute achilles tendon rupture: the influence of early weight-bearing on clinical outcome: a blinded, randomized controlled trial. J Bone Joint Surg Am, 2014. 96(18): p. 1497-503.
Who may be able to join
- Suffered acute Achilles tendon rupture from April 2011 to March 2012, and then referred to Copenhagen University Hospital Hvidovre.
- Participated and completed the original study.
- The patient must be able to speak and understand Danish, as well as be capable to give informed consent to participating.
Who cannot join
- Terminal disease or serious illnesses with an ASA score of 3 or above.
- Any injury significantly influencing gate and function of the lower extremities other than re-rupture of the Achilles tendon.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medium Term Outcome of Nonoperative Dynamic Treatment of Acute Achilles Tendon Rupture: the Influence of Early Weight-bearing on Clinical Outcome: a Blinded, Randomized Controlled Trial.
A total of 56 patients completed a previous study regarding non-operative treatment for acute achilles tendon rupture. This study consists of an additional follow up after 4-5 years depending on original date of injury.
Read the detailed description
30 patients suffering from acute Achilles tendon rupture was originally randomized to each arm, and followed up after 6 and 12 months. Of these a total of 56 patients was included in the final analysis, and invited to participate in this additional follow-up, 4-5 years after their original injury. Originally patients was monitored using: ATRS questionnaires, ATRA: Achilles Tendon Resting Angle, Heel Raise Work: number of lifts, lift height and total work, and tests of strength and stiffness in the ankle using a kinetic dynamometer.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Early weight bearing
- Keywords
- Achilles Tendon Rupture, Conservative treatment, early weight bearing, Dynamic, ATRS, ATRA, Heel Raise Work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early weight bearingBehavioural
The intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks.
| Study group | Role | What they receive |
|---|---|---|
| Early Weight Bearing | Ankle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Full weight bearing was allowed from day 1. The orthosis was worn 24 hours / day the first 2 weeks.
From week 2 controlled motion exercises and removal of the orthosis 5 times a day. Receives: Behavioral: Early weight bearing | |
| Control | Ankle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Weight bearing was allowed from week 6. The orthosis was worn 24 hours / day the first 2 weeks. From week 2 controlled motion exercises and removal of the orthosis 5 times a day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATRS: Achilles Tendon Rupture Score
From initial test 6 and 12 months after injury, and now 4-5 years after.
Measured: approximate 5 years
Secondary outcomes (2)
Heel Raise Work
The total work (joules), max height of lift (mm) and number of lifts is recorded. THe patient is placed standing on one leg on a platform tilted 10 degrees (heel below toes), and is asked to lift the heel (and thereby bodyweight) as high as possible, once every 2 seconds. When the patient can no longer maintain height or pace, the test is finished.
Measured: Test is performed once, 4-5 years after the initial injury
return to sport and return to work
When did the patients return to work full or part time, and when did they take up sports again.
Measured: 4-5 years after the initial injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Kastoft, Copenhagen University Hospital, Hvidovre
- Investigators
- Jeannette Penny, MD, PhD, Study director, Copenhagen University Hospital, HvidovreRasmus Kastoft, Stud. Med., Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760784
- Sponsor's protocol ID
- 16015461-1
- Status last verified
- Aug 2017
- First submitted
- 25 Apr 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share data
Publications
Barfod KW, Bencke J, Lauridsen HB, Ban I, Ebskov L, Troelsen A. Nonoperative dynamic treatment of acute achilles tendon rupture: the influence of early weight-bearing on clinical outcome: a blinded, randomized controlled trial. J Bone Joint Surg Am. 2014 Sep 17;96(18):1497-503. doi: 10.2106/JBJS.M.01273.
PubMed 25232073Kastoft R, Barfod K, Bencke J, Speedtsberg MB, Hansen SB, Penny JO. 1.7 cm elongated Achilles tendon did not alter walking gait kinematics 4.5 years after non-surgical treatment. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3579-3587. doi: 10.1007/s00167-022-06874-y. Epub 2022 Mar 2.
PubMed 35234975Speedtsberg MB, Kastoft R, Barfod KW, Penny JO, Bencke J. Gait Function and Postural Control 4.5 Years After Nonoperative Dynamic Treatment of Acute Achilles Tendon Ruptures. Orthop J Sports Med. 2019 Jun 27;7(6):2325967119854324. doi: 10.1177/2325967119854324. eCollection 2019 Jun.
PubMed 31276005Kastoft R, Bencke J, Speedtsberg MB, Penny JO, Barfod K. Early weight-bearing in nonoperative treatment of acute Achilles tendon rupture did not influence mid-term outcome: a blinded, randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2019 Sep;27(9):2781-2788. doi: 10.1007/s00167-018-5058-4. Epub 2018 Jul 20.
PubMed 30030579
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium Term Outcome of Nonoperative Dynamic Treatment of Acute Achilles Tendon Rupture: the Influence of Early Weight-bearing on Clinical Outcome: a Blinded, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02760784
- Acronym / sponsor ID
- 16015461-1
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles Tendon Rupture, Conservative treatment, early weight bearing, Dynamic, ATRS, ATRA, Heel Raise Work
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 56 patients completed a previous study regarding non-operative treatment for acute achilles tendon rupture. This study consists of an additional follow up after 4-5 years depending on original date of injury.
Detailed description
30 patients suffering from acute Achilles tendon rupture was originally randomized to each arm, and followed up after 6 and 12 months. Of these a total of 56 patients was included in the final analysis, and invited to participate in this additional follow-up, 4-5 years after their original injury. Originally patients was monitored using: ATRS questionnaires, ATRA: Achilles Tendon Resting Angle, Heel Raise Work: number of lifts, lift height and total work, and tests of strength and stiffness in the ankle using a kinetic dynamometer.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Weight Bearing | – | Behavioral: Early weight bearingAnkle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Full weight bearing was allowed from day 1. The orthosis was worn 24 hours / day the first 2 weeks. From week 2 controlled motion exercises and removal of the orthosis 5 times a day. |
| Control | – | –Ankle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Weight bearing was allowed from week 6. The orthosis was worn 24 hours / day the first 2 weeks. From week 2 controlled motion exercises and removal of the orthosis 5 times a day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who participated and completed the original study: Barfod, K.W., et al., Nonoperative dynamic treatment of acute achilles tendon rupture: the influence of early weight-bearing on clinical outcome: a blinded, randomized controlled trial. J Bone Joint Surg Am, 2014. 96(18): p. 1497-503.
Key inclusion criteria (3 listed)
- Suffered acute Achilles tendon rupture from April 2011 to March 2012, and then referred to Copenhagen University Hospital Hvidovre.
- Participated and completed the original study.
- The patient must be able to speak and understand Danish, as well as be capable to give informed consent to participating.
Key exclusion criteria (2 listed)
- Terminal disease or serious illnesses with an ASA score of 3 or above.
- Any injury significantly influencing gate and function of the lower extremities other than re-rupture of the Achilles tendon.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early weight bearingThe intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks. | Behavioural | Early Weight Bearing |
Primary outcome
ATRS: Achilles Tendon Rupture Score
Time frame: approximate 5 years
From initial test 6 and 12 months after injury, and now 4-5 years after.
2 secondary outcomes
Heel Raise Work
Time frame: Test is performed once, 4-5 years after the initial injury
return to sport and return to work
Time frame: 4-5 years after the initial injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Background: PubMed 25232073Barfod KW, Bencke J, Lauridsen HB, Ban I, Ebskov L, Troelsen A. Nonoperative dynamic treatment of acute achilles tendon rupture: the influence of early weight-bearing on clinical outcome: a blinded, randomized controlled trial. J Bone Joint Surg Am. 2014 Sep 17;96(18):1497-503. doi: 10.2106/JBJS.M.01273.
- Derived from this study: PubMed 35234975Kastoft R, Barfod K, Bencke J, Speedtsberg MB, Hansen SB, Penny JO. 1.7 cm elongated Achilles tendon did not alter walking gait kinematics 4.5 years after non-surgical treatment. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3579-3587. doi: 10.1007/s00167-022-06874-y. Epub 2022 Mar 2.
- Derived from this study: PubMed 31276005Speedtsberg MB, Kastoft R, Barfod KW, Penny JO, Bencke J. Gait Function and Postural Control 4.5 Years After Nonoperative Dynamic Treatment of Acute Achilles Tendon Ruptures. Orthop J Sports Med. 2019 Jun 27;7(6):2325967119854324. doi: 10.1177/2325967119854324. eCollection 2019 Jun.
- Derived from this study: PubMed 30030579Kastoft R, Bencke J, Speedtsberg MB, Penny JO, Barfod K. Early weight-bearing in nonoperative treatment of acute Achilles tendon rupture did not influence mid-term outcome: a blinded, randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2019 Sep;27(9):2781-2788. doi: 10.1007/s00167-018-5058-4. Epub 2018 Jul 20.
- Individual participant dataSharing planned: No. No plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannette Penny, MD, PhD study director
Copenhagen University Hospital, Hvidovre
Rasmus Kastoft, Stud. Med. principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon Rupture, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ATRS: Achilles Tendon Rupture Score (time frame: approximate 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760784, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.