Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV

Completed

• Conditions: Degenerative Lesion of Articular Cartilage of Knee
• Interventions: Procedure: knee surgery

• Registration Number: NCT01554878
• Lead Sponsor: Ettore Sansavini Health Science Foundation

Brief Summary

The purpose of the study is to evaluate prospectively the outcome of treatment interventions of knee osteochondral lesions Outerbridge grade III and IV.

Detailed Description

The main purpose of the study is to prospectively evaluate the outcome of treatment interventions with replacement, repair and regenerative approaches, of osteochondral articular lesions or defects, Outerbridge grade III and IV, in terms of symptomatic and functional recovery 12 months after surgery.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Primary Completion: 2014-03
• Status Verified: 2014-05
• Study Completion: 2014-11
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
knee surgery	knee surgery	-

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score	12 months post procedure	Primary outcome measure will be the outcome of innovative treatments with repairing, regenerative and replacement techniques, with or without associated osteotomy, of knee osteochondral severe lesions(Outerbridge grade III and IV) in terms of symptoms improvement as assessed by means of the International Knee Documentation Committee (IKDC) subjective Knee Evaluation Score at 12 months postoperatively.

Secondary Outcome Measures

Name	Time	Method
functional recovery at International Knee Documentation Committee(IKDC) knee Examination	12 months
Tissue regeneration at magnetic resonance (MRI)	12 months post surgery
Physical performance at Tegner activity score	12 months post surgery
functional activity on the Lysholm Knee Scale	12 months post surgery

Trial Locations

Locations (4)

Raul Zini; 🇮🇹 Cotignola, Ravenna, Italy

Andrea Mocci; 🇮🇹 Bari, Italy

Maurizio Bellettato; 🇮🇹 Faenza, Ravenna, Italy

Luisangelo Sordo; 🇮🇹 Torino, Italy