Comparison of Surgical Outcomes Between Avulsion Fracture of the AT and Conventional ATR--a Retrospective Study

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04957069
Collaborator
(none)
60
65.9

Study Details

Study Description

Brief Summary

To compare the surgical outcomes between avulsion fracture of the Achilles tendon and conventional Achilles tendon rupture, collected and analysed information of patients preoperatively and postoperatively.

Condition or Disease Intervention/Treatment Phase
  • Procedure: fixation
  • Procedure: primary repair

Detailed Description

Include 30 patients with avulsion fracture of the Achilles tendon and 30 patients with Achilles tendon rupture underwent surgical treatment in our institute. Collect and evaluate MRI, VAS, AOFAS, and FFI score preoperatively and postoperatively. Finally explore the surgical outcomes between avulsion fracture of the AT and conventional ATR.

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of Surgical Outcomes Between Avulsion Fracture of the Achilles Tendon and Conventional Achilles Tendon Rupture--a Retrospective Study
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Mar 31, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Avulsion fracture

avulsion fracture of the Achilles tendon

Procedure: fixation
double row fixation with 3-4 wire anchors

Rupture

Achilles tendon rupture

Procedure: primary repair
end-to-end repair

Outcome Measures

Primary Outcome Measures

  1. MOCART [one year after sugery]

    MOCART is a scoring system to evaluate the repair effect of cartilage injury.The minimum and maximum values of MOCART are 100 and 0, respectively. And higher scores mean a better outcome.

Secondary Outcome Measures

  1. VAS [pre-surgery, one year after sugery]

    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.

  2. AOFAS [pre-surgery, one year after sugery]

    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.

  3. FFI [pre-surgery, one year after sugery]

    A Foot Function Index (FFI) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The FFI was examined for test-retest reliability, internal consistency, and construct and criterion validity. Each scale is from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) .

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture
Exclusion Criteria:
  • neuromuscular related diseases

  • other injuries of ankle joint

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Study Chair: Qinwei Guo, MD, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04957069
Other Study ID Numbers:
  • M2018040
First Posted:
Jul 12, 2021
Last Update Posted:
Jul 12, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2021