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Completed

NCT Number: NCT01554878

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

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

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Key information

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Andrea Mocci, Bari, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

knee surgery

Procedure

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

Primary outcomes

  1. 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

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

    Time frame: 12 months

  2. Physical performance at Tegner activity score

    Time frame: 12 months post surgery

  3. functional activity on the Lysholm Knee Scale

    Time frame: 12 months post surgery

  4. Tissue regeneration at magnetic resonance (MRI)

    Time frame: 12 months post surgery

Sponsors and collaborators

Lead sponsor

Ettore Sansavini Health Science Foundation

Other

Registry information

Official study title

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

Acronym: LOGIC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 15, 2012
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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