NCT04950335

Brief Summary

Autologous osteoperiosteal transplantation using tissue harvested from the iliac crest is used to treat large cystic osteochondral lesions of the talus. This study is to compare clinical and radiological outcomes between patients undergoing AOPT and those undergoing AOCT for large cystic OLTs.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
Last Updated

July 6, 2021

Status Verified

June 1, 2021

Enrollment Period

3.8 years

First QC Date

June 25, 2021

Last Update Submit

July 1, 2021

Conditions

Osteochondral Lesions of the Talus

Outcome Measures

Primary Outcomes (1)

  • MOCART

    the Magnetic Resonance Observation of Cartilage Repair Tissue score

    two years after sugery

Secondary Outcomes (4)

  • VAS

    pre-surgery, two years after sugery

  • Tegner

    pre-surgery, two years after sugery

  • AOFAS

    pre-surgery, two years after sugery

  • ICRS

    one year after sugery

Study Arms (2)

AOPT

patients underwent AOPT to treat large cystic OLTs (\>10mm)

Procedure: AOPT

AOCT

patients underwent AOCT to treat large cystic OLTs (\>10mm)

Procedure: AOCT

Interventions

AOPTPROCEDURE

The Osteochondral Autograft Transplant System (Arthrex) was used to create donor plugs. Osteoperiosteal grafts were harvested from the ipsilateral anterior superior iliac spine.

AOPT
AOCTPROCEDURE

Osteochondral grafts were harvested from the non-weight-bearing zone of the ipsilateral anterolateral distal femur.

AOCT

Eligibility Criteria

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

Patients with symptomatic OLTs who underwent AOPT or AOCTvat our sports medicine institute between March, 2015 and March, 2018

You may qualify if:

  • presence of medial large cystic OLTs (\>10 mm in diameter) confirmed by preoperative magnetic resonance imaging (MRI)
  • patients who underwent either primary AOPT or AOCT

You may not qualify if:

  • small cystic OLTs
  • ankle osteoarthritis
  • ankle pigmented villonodular synovitis
  • prior surgery on the ipsilateral ankle
  • injuries or relevant trauma to the affected ankle after surgery

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 6, 2021

Study Start

March 1, 2014

Primary Completion

November 30, 2017

Study Completion

November 10, 2020

Last Updated

July 6, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share