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Clinical Trials/NCT01554878
NCT01554878
Completed
Not Applicable

Observational Studies, Prospective, Multicenter, to Evaluate the Effect of Treatment of Knee Osteochondral Lesions of Outerbridge Grade III-IV

Ettore Sansavini Health Science Foundation4 sites in 1 country20 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Degenerative Lesion of Articular Cartilage of Knee
Sponsor
Ettore Sansavini Health Science Foundation
Enrollment
20
Locations
4
Primary Endpoint
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
November 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ettore Sansavini Health Science Foundation
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score

Time Frame: 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 Outcomes

  • 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)

Study Sites (4)

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