Achilles Tendon RuptureNCT01622179
Outcome of Two Different Suture Methods for Achilles Tendon Rupture
A study testing sewed indirectly and sewed directly in people with Achilles Tendon Rupture, run by Peifu Tang at 1 site in China.
Trial summary
The purpose of this study is to estimate the effective of two suture methods in the treatment of Achilles rupture. 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?
- sewed indirectly and sewed directly
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jun 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult men or women between 18 and 60 years of age.
- Closed rupture confirmed with ultrasound or magnetic resonance imaging (MRI).
- Operative within 14 days after injury.
- Willing and able to comply with and carry out the prescribed rehabilitation protocol.
- Providing informed consent.
- No other major trauma.
Who cannot join
- Refuse to participate.
- Refuse to participate.
- Additional ipsilateral injury.
- Open injury.
- Patients not suitable for surgery (i.e., mellitus diabetes, immunocompromised states, obesity (BMI.30), peripheral vascular disease or local/systemic dermatologic disorders) or have other surgical contraindications.
- Fluoroquinolone-associated rupture (i.e., rupture within 2 weeks after taking this medication).
- Achilles avulsion from the calcaneus or with bone fracture.
- Neurological or vascular disease requiring medications recognized to impair tendon healing.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Orthopedics department; The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, 100853
Tang P Fu, Dr., 861099638101, pftang301@126.com
Zhang L Hai, Dr.
About this study
Official title: Closed Achilles Tendon Rupture Treats by Two Different Suture Methods and the Outcome
The purpose of this study is to estimate the effective of two suture methods in the treatment of Achilles rupture.
Read the detailed description
Achilles tendon rupture is one of the most common tendon injuries in the adult population. The incidence of this injury is increasing as aging adults continue their participation in high-demand sports. Although the impact of an Achilles tendon rupture is substantial, often resulting in prolonged disability and rehabilitation. Studies have showed that the operation treatment of acute Achilles tendon ruptures had some advantages. But the rebuild of blood supply was not involved in previous studies. And the epitenon of tendon is the interior layer, closest to the endotenons which contains the vascular supply. Main difference of two suture methods were if the epitenon was repaired and sewed indirectly or unrepaired and sewed directly.
- Conditions
- Achilles Tendon Rupture
- Being tested
- sewed indirectly, sewed directly
- Keywords
- surgery, suture method, blood supply
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sewed indirectlyProcedure or surgery
The epitenon was repaired and sewed indirectly.
sewed directlyProcedure or surgery
The epitenon was unrepaired and sewed directly.
| Study group | Role | What they receive |
|---|---|---|
| Indirectly | Experimental | The epitenon was repaired and sewed indirectly. Receives: Procedure: sewed indirectly |
| Directly | Placebo comparator | The epitenon was unrepaired and sewed directly. Receives: Procedure: sewed directly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood supply condition
Blood supply was estimated by ultrasonic contrast at six weeks after surgery.
Measured: six weeks
Secondary outcomes (2)
Calf circumference
Calf circumference was measured at six weeks after surgery.
Measured: six weeks
Complications
Infection and rerupture at six month after surgery.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peifu Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peifu Tang, Chinese PLA General Hospital
- Investigators
- Tang P Fu, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622179
- Sponsor's protocol ID
- PLAGH OD 13
- Status last verified
- Feb 2013
- First submitted
- 5 Jun 2012
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Achilles Tendon Rupture Treats by Two Different Suture Methods and the Outcome
- ClinicalTrials.gov ID
- NCT01622179
- Acronym / sponsor ID
- PLAGH OD 13
- Conditions
- Achilles Tendon Rupture
- Keywords
- surgery, suture method, blood supply
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peifu TangUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 19 Jun 2012 (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 purpose of this study is to estimate the effective of two suture methods in the treatment of Achilles rupture.
Detailed description
Achilles tendon rupture is one of the most common tendon injuries in the adult population. The incidence of this injury is increasing as aging adults continue their participation in high-demand sports. Although the impact of an Achilles tendon rupture is substantial, often resulting in prolonged disability and rehabilitation. Studies have showed that the operation treatment of acute Achilles tendon ruptures had some advantages. But the rebuild of blood supply was not involved in previous studies. And the epitenon of tendon is the interior layer, closest to the endotenons which contains the vascular supply. Main difference of two suture methods were if the epitenon was repaired and sewed indirectly or unrepaired and sewed directly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indirectly | Experimental | Procedure: sewed indirectlyThe epitenon was repaired and sewed indirectly. |
| Directly | Placebo comparator | Procedure: sewed directlyThe epitenon was unrepaired and sewed directly. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult men or women between 18 and 60 years of age.
- Closed rupture confirmed with ultrasound or magnetic resonance imaging (MRI).
- Operative within 14 days after injury.
- Willing and able to comply with and carry out the prescribed rehabilitation protocol.
- Providing informed consent.
Key exclusion criteria (8 listed)
- Refuse to participate.
- Refuse to participate.
- Additional ipsilateral injury.
- Open injury.
- Patients not suitable for surgery (i.e., mellitus diabetes, immunocompromised states, obesity (BMI.30), peripheral vascular disease or local/systemic dermatologic disorders) or have other surgical contraindications.
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 |
|---|---|---|
| sewed indirectlyThe epitenon was repaired and sewed indirectly. | Procedure or surgery | Indirectly |
| sewed directlyThe epitenon was unrepaired and sewed directly. | Procedure or surgery | Directly |
Primary outcome
Blood supply condition
Time frame: six weeks
Blood supply was estimated by ultrasonic contrast at six weeks after surgery.
2 secondary outcomes
Calf circumference
Time frame: six weeks
Complications
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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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.
Tang P Fu study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sewed indirectly and sewed directly in people with Achilles Tendon Rupture, run by Peifu Tang at 1 site in China.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Feb 2013. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tang P Fu, Dr. (861099638101, pftang301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood supply condition (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2013.