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

NCT01554878 | Completed

• 1 other identifier: ESREFO08
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Keywords

osteochondral defect of the knee

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• functional recovery at International Knee Documentation Committee(IKDC) knee Examination

  12 months

• Physical performance at Tegner activity score

  12 months post surgery

• functional activity on the Lysholm Knee Scale

  12 months post surgery

• Tissue regeneration at magnetic resonance (MRI)

  12 months post surgery

Study Arms (1)

knee surgery

Procedure: knee surgery

Interventions

knee surgery PROCEDURE

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

knee surgery

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients with synovitis;
• BMI\> 30;
• Allergy to collagen or calcium phosphate;
• Patients with neoplastic disease;
• Patients with metabolic disorders, thyroid diseases, immune system disorders.

Sponsors & Collaborators

• Ettore Sansavini Health Science Foundation: lead

Study Sites (4)

Andrea Mocci

Bari, Bari, 70124, Italy

Location

Raul Zini

Cotignola, Ravenna, 48010, Italy

Location

Maurizio Bellettato

Faenza, Ravenna, 48018, Italy

Location

Luisangelo Sordo

Torino, Torino, 10132, Italy

Location

Study Officials

• Raul Zini, MD

  Maria Cecilia Hospital

  STUDY DIRECTOR

• Luisangelo Sordo, MD

  MARIA PIA HOSPITAL

  PRINCIPAL INVESTIGATOR

• Maurizio Bellettato, MD

  SAN PIER DAMIANO

  PRINCIPAL INVESTIGATOR

• Andrea Mocci, MD

  ANTHEA HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 15, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 3, 2016

Record last verified: 2014-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)