Acute Rupture of Achilles Tendon (Disorder) Clinical Trial
Official title:
Comparison of Mid-term Curative Effect After Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture
| NCT number | NCT04465994 |
| Other study ID # | M2019465 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 5, 2020 |
| Est. completion date | May 5, 2020 |
| Verified date | June 2020 |
| Source | Peking University Third Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, aiming to compare the mid-term curative effect of primary repair and gastrocnemius turn-down flaps and guide clinical decision.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | May 5, 2020 |
| Est. primary completion date | February 5, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 65 Years |
| Eligibility |
Inclusion Criteria: - history of Achilles tendon injury - within two weeks of injury - inability to single heel rise - more than one year of follow-up - age under 65 Exclusion Criteria: - open Achilles tendon rupture - Achilles tendon terminal disease - rerupture of Achilles tendon - history of local corticosteroid injection around the Achilles tendon - accompanied by fracture, vascular or nerve damage - not available for regular follow-up |
| Country | Name | City | State |
|---|---|---|---|
| China | Peking Univerisity Third Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University Third Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of Visual Analogue Scale | The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome. | from pre-surgery to two years after surgery | |
| Primary | change of American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score | The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome. | from pre-surgery to two years after surgery | |
| Primary | change of The Victorian Institute of Sport Assessment-Achilles | The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score. | from pre-surgery to two years after surgery | |
| Primary | change of The Achilles tendon Total Rupture Score | The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score. | from pre-surgery to two years after surgery | |
| Primary | change of the Tegner Activity Score | The Tegner activity scale was first described in 1985 and initially designed for physician administration after ACL and meniscal injuries. To date, the Tegner activity score has been a frequently used patient-administered activity rating system for patients with various knee disorders. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer. | from pre-surgery to two years after surgery | |
| Primary | Biodex | Biodex isokinetic dynamometer system | through study completion, an average of 2 years | |
| Secondary | complications | rerupture, infection, wound scar | through study completion, an average of 2 years |