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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01554878
Acronym
LOGIC
Enrollment
20
Registered
2012-03-15
Start date
2012-01-31
Completion date
2014-11-30
Last updated
2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Keywords

osteochondral defect of the knee

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.

Interventions

PROCEDUREknee surgery

Reparative, replacement or regenerative techniques, with or without associated osteotomy.

Sponsors

Ettore Sansavini Health Science Foundation
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score12 months post procedurePrimary 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

MeasureTime frame
functional activity on the Lysholm Knee Scale12 months post surgery
Tissue regeneration at magnetic resonance (MRI)12 months post surgery
functional recovery at International Knee Documentation Committee(IKDC) knee Examination12 months
Physical performance at Tegner activity score12 months post surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026