Completed

NCT Number: NCT04950335

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

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.

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Key information

Conditions

Osteochondral Lesions of the Talus

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AOPT

Procedure

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

AOCT

Procedure

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

Primary outcomes

MOCART

Time frame: two years after sugery

the Magnetic Resonance Observation of Cartilage Repair Tissue score

Secondary outcomes

VAS

Time frame: pre-surgery, two years after sugery

the visual analog scale
Tegner

Time frame: pre-surgery, two years after sugery

the Tegner score
AOFAS

Time frame: pre-surgery, two years after sugery

American Orthopaedic Foot & Ankle Society score
ICRS

Time frame: one year after sugery

the International Cartilage Repair Society score

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2020
First posted: Jul 6, 2021
Registry last updated: Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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