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

Degenerative Lesion of Articular Cartilage of Knee Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554878
• Other study ID #: ESREFO08
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: September 30, 2016
• Start date: January 2012
• Est. completion date: November 2014

Study information

• Verified date: May 2014
• Source: Ettore Sansavini Health Science Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion criteria:

patients referred to the participating centers for symptomatic treatment of degenerative lesions of the knee, which meet the following inclusion criteria:

• symptomatic osteochondral lesions of grade III or IV (according to classification of Outerbridge;

• Axial deviation with chondral damage, correct or not;

• Consent to the processing of personal data, signed and dated by patient;

• Patients of both sexes and aged between 30 and 60 years;

• Patients willing to participate actively in the rehabilitation program and to attend post-operative follow-up visits.

Exclusion criteria:

• Patients with synovitis;

• BMI> 30;

• Allergy to collagen or calcium phosphate;

• Patients with neoplastic disease;

• Patients with metabolic disorders, thyroid diseases, immune system disorders.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Lesion of Articular Cartilage of Knee

Intervention

Procedure:
• knee surgery
Reparative, replacement or regenerative techniques, with or without associated osteotomy.

Locations

Country	Name	City	State
Italy	Andrea Mocci	Bari
Italy	Raul Zini	Cotignola	Ravenna
Italy	Maurizio Bellettato	Faenza	Ravenna
Italy	Luisangelo Sordo	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Ettore Sansavini Health Science Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score	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.	12 months post procedure	No
Secondary	functional recovery at International Knee Documentation Committee(IKDC) knee Examination		12 months	No
Secondary	Physical performance at Tegner activity score		12 months post surgery	No
Secondary	functional activity on the Lysholm Knee Scale		12 months post surgery	No
Secondary	Tissue regeneration at magnetic resonance (MRI)		12 months post surgery	No