Achilles Tendon RuptureNCT02012803
Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial
A study testing End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and Conservative treatment of achilles tendon rupture in people with Achilles Tendon Rupture, run by University of Oulu at 1 site in Finland.
Trial summary
The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and Conservative treatment of achilles tendon rupture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2009to Dec 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years, Clinical diagnosis of total achilles tendon rupture, ultrasonography controlled tendon ends reposition when ankle is in equinus/ plantar flexion.
Who cannot join
- earlier achilles tendon disorders, corticosteroid injections in achilles tendon, fluorokinolol-antibiotics in 2 years earlier, systemic corticosteroid medication, diabetes, peripheral arterial disease, more than 7 days old rupture, patient lives abroad or patient refused to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial
The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months.
Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.
- Conditions
- Achilles Tendon Rupture
- Being tested
- End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture, Conservative treatment of achilles tendon rupture
- Keywords
- Achilles tendon rupture, treatment, elongation, operative treatment of achilles tendon rupture, conservative treatment of achilles tendon rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire sutureProcedure or surgery
Operative treatment of achilles tendon rupture; End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and after operation identical protocol as conservative treatment.
Conservative treatment of achilles tendon ruptureOther
Conservative treatment of achilles tendon rupture; 1 week equinus-cast without bearing, and then 6 week Vacoped orthosis with different equinus degrees and full weight bearing.
| Study group | Role | What they receive |
|---|---|---|
| Operative treatment | Experimental | Not described Receives: Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture |
| conservative treatment | Active comparator | Not described Receives: Other: Conservative treatment of achilles tendon rupture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.
Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire. Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.
Measured: 18 months
Secondary outcomes (2)
Complications in treatment of achilles tendon rupture.
Complications are re-rupture and postoperative infection.
Measured: 18 months
Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.
We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startApr 2009
- Primary completionDec 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012803
- Sponsor's protocol ID
- Evo-rad-akilles-2
- Status last verified
- Oct 2018
- First submitted
- 27 Nov 2013
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Heikkinen J, Lantto I, Flinkkila T, Ohtonen P, Niinimaki J, Siira P, Laine V, Leppilahti J. Soleus Atrophy Is Common After the Nonsurgical Treatment of Acute Achilles Tendon Ruptures: A Randomized Clinical Trial Comparing Surgical and Nonsurgical Functional Treatments. Am J Sports Med. 2017 May;45(6):1395-1404. doi: 10.1177/0363546517694610. Epub 2017 Mar 10.
PubMed 28282504Lantto I, Heikkinen J, Flinkkila T, Ohtonen P, Siira P, Laine V, Leppilahti J. A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures. Am J Sports Med. 2016 Sep;44(9):2406-14. doi: 10.1177/0363546516651060. Epub 2016 Jun 15.
PubMed 27307495
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02012803
- Acronym / sponsor ID
- Evo-rad-akilles-2
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles tendon rupture, treatment, elongation, operative treatment of achilles tendon rupture, conservative treatment of achilles tendon rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Dec 2013 (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.
The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months.
Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative treatment | Experimental | Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture |
| conservative treatment | Active comparator | Other: Conservative treatment of achilles tendon rupture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 years, Clinical diagnosis of total achilles tendon rupture, ultrasonography controlled tendon ends reposition when ankle is in equinus/ plantar flexion.
Key exclusion criteria (1 listed)
- earlier achilles tendon disorders, corticosteroid injections in achilles tendon, fluorokinolol-antibiotics in 2 years earlier, systemic corticosteroid medication, diabetes, peripheral arterial disease, more than 7 days old rupture, patient lives abroad or patient refused to participate.
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 |
|---|---|---|
| End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire sutureOperative treatment of achilles tendon rupture; End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and after operation identical protocol as conservative treatment. | Procedure or surgery | Operative treatment |
| Conservative treatment of achilles tendon ruptureConservative treatment of achilles tendon rupture; 1 week equinus-cast without bearing, and then 6 week Vacoped orthosis with different equinus degrees and full weight bearing. | Other | conservative treatment |
Primary outcome
Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.
Time frame: 18 months
Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire. Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.
2 secondary outcomes
Complications in treatment of achilles tendon rupture.
Time frame: 18 months
Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.
Time frame: 18 months
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 11 Oct 2018.
- Derived from this study: PubMed 28282504Heikkinen J, Lantto I, Flinkkila T, Ohtonen P, Niinimaki J, Siira P, Laine V, Leppilahti J. Soleus Atrophy Is Common After the Nonsurgical Treatment of Acute Achilles Tendon Ruptures: A Randomized Clinical Trial Comparing Surgical and Nonsurgical Functional Treatments. Am J Sports Med. 2017 May;45(6):1395-1404. doi: 10.1177/0363546517694610. Epub 2017 Mar 10.
- Derived from this study: PubMed 27307495Lantto I, Heikkinen J, Flinkkila T, Ohtonen P, Siira P, Laine V, Leppilahti J. A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures. Am J Sports Med. 2016 Sep;44(9):2406-14. doi: 10.1177/0363546516651060. Epub 2016 Jun 15.
Related trials for Achilles Tendon Rupture
Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles Rupture
RecruitingObservational study
Achilles Tendon Rupture Patient Outcomes at 12 Months
Achilles Tendon Rupture
Recruiting
Effect of BFR Rehab After Achilles Tendon Rupture
Achilles Tendon Rupture
Active, not recruiting
Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders
Tendon Tear, Tendinopathy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and Conservative treatment of achilles tendon rupture in people with Achilles Tendon Rupture, run by University of Oulu at 1 site in Finland.
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 1 inclusion and 1 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 11 Oct 2018. 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 Finland. 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?
Subjective and objective results in conservative and operative treatment of Achilles tendon rupture. (time frame: 18 months). 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 NCT02012803, which also lists 2 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 11 Oct 2018.