Acute Rupture of Achilles TendonNCT04935281
Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound
An observational study of Acute Rupture of Achilles Tendon, run by Tanta University.
Trial summary
This is a prospective randomized controlled study carried out between May 2016 and December 2020. It included 98 patients presented with acute rupture of Achilles tendon The patients were randomly distributed by closed envelop technique (49 in each group). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Rupture of Achilles Tendon
- What is being tested?
- percutaneous repair with an intraoperative assisted ultrasound and percutaneous repair without an intraoperative assisted ultrasound
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: a prospective randomized control study
Who may be able to join
- age between 18 and 50 years
- acute ( not more than two weeks) closed complete injury
- injury of Achilles tendon in zone 2 (the area between 3 and 6 cm from the insertion) according to Langergran and Lindholm
Who cannot join
- incomplete injury
- recurrent injury
- associated fracture ankle or foot
- previous history of local corticosteroids injection
- patients with neurovascular problem (e.g. diabetic, autoimmune …etc), smoking, and alcoholics
About this study
Official title: Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound: Does it Improves the Results of Repair?
This is a prospective randomized controlled study carried out between May 2016 and December 2020. It included 98 patients presented with acute rupture of Achilles tendon The patients were randomly distributed by closed envelop technique (49 in each group). Group A included those managed with the assistant of an intra-operative ultrasound. Group B included those done without ultrasound assistant
Read the detailed description
A preoperative prophylactic dose of antibiotic was given intravenously in the form of 2gm of cephalosporin one hour before operation. Under general or regional anesthesia, the patient laid in prone position without a tourniquet and both feet out of the table for easily mobilization of the ankle joint. In group A, an intraoperative ultrasound was done by a radiologist before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon. Then ultrasound was repeated after repair for confirmation of adequate contact of both stumps and satisfactory strength of the repair by visualization of the tendon with passive motion of the ankle. For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al. This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon. The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. The technique of repair was standardized for all patients in both groups. We used the technique described by Maffulli et al
- Conditions
- Acute Rupture of Achilles Tendon
- Being tested
- percutaneous repair with an intraoperative assisted ultrasound, percutaneous repair without an intraoperative assisted ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous repair with an intraoperative assisted ultrasoundOther
Under general or regional anesthesia, the patient laid in prone position In group A, an intraoperative ultrasound was done by a radiologist before the repair .
percutaneous repair without an intraoperative assisted ultrasoundOther
For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al.The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. We used the technique described byMaffulli et al with six stab incisions, one cm each. Four incisions were on medial and lateral edge of the proximal stump and the other two were around distal stump.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous repair with an intraoperative assissted ultrasound | a radiologist did an intraoperative ultrasound before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon. Receives: Other: percutaneous repair with an intraoperative assisted ultrasound | |
| percutaneous repair without an intraoperative assissted ultrasound | the course of the sural nerve was determined according to the technique described by Blackmon et al .This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon Receives: Other: percutaneous repair without an intraoperative assisted ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and An¬kle Society score
score from 0 to 100 with highest score is better
Measured: 4 years
single leg rising
ability to stand on one leg
Measured: 3 years
magnetic resonance image
assessment of healing of torn tendon
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study startMay 2016
- Primary completionMar 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Rupture of Achilles TendonStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed m. samy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935281
- Sponsor's protocol ID
- Tanta H
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Samy AM. Intra-operative ultrasound: does it improve the results of percutaneous repair of acute Achilles tendon rupture? Eur J Trauma Emerg Surg. 2022 Oct;48(5):4061-4068. doi: 10.1007/s00068-022-01926-x. Epub 2022 Mar 11.
PubMed 35275242
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound: Does it Improves the Results of Repair?
- ClinicalTrials.gov ID
- NCT04935281
- Acronym / sponsor ID
- Tanta H
- Conditions
- Acute Rupture of Achilles Tendon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 22 Jun 2021 (actual)
- 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.
This is a prospective randomized controlled study carried out between May 2016 and December 2020. It included 98 patients presented with acute rupture of Achilles tendon The patients were randomly distributed by closed envelop technique (49 in each group). Group A included those managed with the assistant of an intra-operative ultrasound. Group B included those done without ultrasound assistant
Detailed description
A preoperative prophylactic dose of antibiotic was given intravenously in the form of 2gm of cephalosporin one hour before operation. Under general or regional anesthesia, the patient laid in prone position without a tourniquet and both feet out of the table for easily mobilization of the ankle joint. In group A, an intraoperative ultrasound was done by a radiologist before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon. Then ultrasound was repeated after repair for confirmation of adequate contact of both stumps and satisfactory strength of the repair by visualization of the tendon with passive motion of the ankle. For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al. This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon. The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. The technique of repair was standardized for all patients in both groups. We used the technique described by Maffulli et al
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutaneous repair with an intraoperative assissted ultrasound | – | Other: percutaneous repair with an intraoperative assisted ultrasounda radiologist did an intraoperative ultrasound before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon. |
| percutaneous repair without an intraoperative assissted ultrasound | – | Other: percutaneous repair without an intraoperative assisted ultrasoundthe course of the sural nerve was determined according to the technique described by Blackmon et al .This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- a prospective randomized control study
Key inclusion criteria (3 listed)
- age between 18 and 50 years
- acute ( not more than two weeks) closed complete injury
- injury of Achilles tendon in zone 2 (the area between 3 and 6 cm from the insertion) according to Langergran and Lindholm
Key exclusion criteria (5 listed)
- incomplete injury
- recurrent injury
- associated fracture ankle or foot
- previous history of local corticosteroids injection
- patients with neurovascular problem (e.g. diabetic, autoimmune …etc), smoking, and alcoholics
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 |
|---|---|---|
| percutaneous repair with an intraoperative assisted ultrasoundUnder general or regional anesthesia, the patient laid in prone position In group A, an intraoperative ultrasound was done by a radiologist before the repair . | Other | percutaneous repair with an intraoperative assissted ultrasound |
| percutaneous repair without an intraoperative assisted ultrasoundFor patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al.The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. We used the technique described byMaffulli et al with six stab incisions, one cm each. Four incisions were on medial and lateral edge of the proximal stump and the other two were around distal stump. | Other | percutaneous repair without an intraoperative assissted ultrasound |
Primary outcome
American Orthopedic Foot and An¬kle Society score
Time frame: 4 years
score from 0 to 100 with highest score is better
single leg rising
Time frame: 3 years
ability to stand on one leg
magnetic resonance image
Time frame: one year
assessment of healing of torn tendon
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 22 Jun 2021.
- Derived from this study: PubMed 35275242Samy AM. Intra-operative ultrasound: does it improve the results of percutaneous repair of acute Achilles tendon rupture? Eur J Trauma Emerg Surg. 2022 Oct;48(5):4061-4068. doi: 10.1007/s00068-022-01926-x. Epub 2022 Mar 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Rupture of Achilles Tendon, run by Tanta University.
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 5 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 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
American Orthopedic Foot and An¬kle Society score (time frame: 4 years). The study lists 3 primary outcomes in all. 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 NCT04935281, which also lists 1 linked publication.
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 22 Jun 2021.