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

NCT ID: NCT01554878

Last Updated: 2016-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Degenerative Lesion of Articular Cartilage of Knee

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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knee surgery

knee surgery

Intervention Type PROCEDURE

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

Interventions

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knee surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ettore Sansavini Health Science Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raul Zini, MD

Role: STUDY_DIRECTOR

Maria Cecilia Hospital

Luisangelo Sordo, MD

Role: PRINCIPAL_INVESTIGATOR

MARIA PIA HOSPITAL

Maurizio Bellettato, MD

Role: PRINCIPAL_INVESTIGATOR

SAN PIER DAMIANO

Andrea Mocci, MD

Role: PRINCIPAL_INVESTIGATOR

ANTHEA HOSPITAL

Locations

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Andrea Mocci

Bari, Bari, Italy

Site Status

Raul Zini

Cotignola, Ravenna, Italy

Site Status

Maurizio Bellettato

Faenza, Ravenna, Italy

Site Status

Luisangelo Sordo

Torino, Torino, Italy

Site Status

Countries

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Italy

Other Identifiers

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ESREFO08

Identifier Type: -

Identifier Source: org_study_id

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