NCT04957069

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

5.2 years

First QC Date

June 25, 2021

Last Update Submit

July 4, 2021

Conditions

Avulsion Fracture of the Achilles TendonAchilles Tendon Rupture

Outcome Measures

Primary Outcomes (1)

  • MOCART

    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.

    one year after sugery

Secondary Outcomes (3)

  • VAS

    pre-surgery, one year after sugery

  • AOFAS

    pre-surgery, one year after sugery

  • FFI

    pre-surgery, one year after sugery

Study Arms (2)

Avulsion fracture

avulsion fracture of the Achilles tendon

Procedure: fixation

Rupture

Achilles tendon rupture

Procedure: primary repair

Interventions

fixationPROCEDURE

double row fixation with 3-4 wire anchors

Avulsion fracture
primary repairPROCEDURE

end-to-end repair

Rupture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

From 2013 to 2017, patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture that underwent surgical treatment in our institute.

You may qualify if:

  • patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture

You may not qualify if:

  • neuromuscular related diseases
  • other injuries of ankle joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Qinwei Guo, MD

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 12, 2021

Study Start

January 1, 2013

Primary Completion

March 31, 2018

Study Completion

June 30, 2018

Last Updated

July 12, 2021

Record last verified: 2021-06