Comparison of AOCT and AOPT for the Treatment of Medial Large Cystic OLT

Comparison of Autologous Osteoperiosteal and Osteochondral Transplantation for the Treatment of Medial Large Cystic Osteochondral Lesions of the Talus

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.

Study Overview

• Status: Completed
• Conditions: Osteochondral Lesions of the Talus
• Intervention / Treatment: Procedure: AOPT; Procedure: AOCT

Detailed Description

From March 2015 to March 2018, 23 patients who underwent AOPT and 23 patients who underwent AOCT to treat large cystic OLTs (>10mm) were retrospectively evaluated. For comparability, the two groups were matched based on their demographics, including sex, age, body mass index, side of injury, follow-up period, and the preoperative cyst volume. Clinical outcomes were assessed using the visual analog scale (VAS), the American Orthopaedic Foot & Ankle Society (AOFAS) score, and the Tegner score. Donor-site morbidity was recorded according to the symptoms, including pain, stiffness, swelling and discomfort. Radiological outcomes were evaluated using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and the International Cartilage Repair Society (ICRS) score was obtained during second-look surgery.

• Study Type: Observational
• Enrollment (Actual): 46

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AOPT; patients underwent AOPT to treat large cystic OLTs (>10mm)	Procedure: AOPT; The Osteochondral Autograft Transplant System (Arthrex) was used to create donor plugs. Osteoperiosteal grafts were harvested from the ipsilateral anterior superior iliac spine.
AOCT; patients underwent AOCT to treat large cystic OLTs (>10mm)	Procedure: AOCT; Osteochondral grafts were harvested from the non-weight-bearing zone of the ipsilateral anterolateral distal femur.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MOCART	the Magnetic Resonance Observation of Cartilage Repair Tissue score	two years after sugery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	the visual analog scale	pre-surgery, two years after sugery
Tegner	the Tegner score	pre-surgery, two years after sugery
AOFAS	American Orthopaedic Foot & Ankle Society score	pre-surgery, two years after sugery
ICRS	the International Cartilage Repair Society score	one year after sugery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: M2021055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No