Outcome of Two Different Suture Methods for Achilles Tendon Rupture
Closed Achilles Tendon Rupture Treats by Two Different Suture Methods and the Outcome
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to estimate the effective of two suture methods in the treatment of Achilles rupture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 20, 2013
February 1, 2013
11 months
June 5, 2012
February 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood supply condition
Blood supply was estimated by ultrasonic contrast at six weeks after surgery.
six weeks
Secondary Outcomes (2)
Calf circumference
six weeks
Complications
six months
Study Arms (2)
Indirectly
EXPERIMENTALThe epitenon was repaired and sewed indirectly.
Directly
PLACEBO COMPARATORThe epitenon was unrepaired and sewed directly.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peifu Tanglead
Study Sites (1)
Orthopedics department; The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, 100853, China
Study Officials
- STUDY CHAIR
Tang P Fu
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief, Professor
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 19, 2012
Study Start
June 1, 2012
Primary Completion
May 1, 2013
Study Completion
June 1, 2013
Last Updated
February 20, 2013
Record last verified: 2013-02