Degenerative Lesion of Articular Cartilage of KneeLOGICNCT01554878
Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV
An observational study of Degenerative Lesion of Articular Cartilage of Knee, run by Ettore Sansavini Health Science Foundation at 4 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Degenerative Lesion of Articular Cartilage of Knee
- What is being tested?
- knee surgery
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 4 sitesItaly
- Study dates
- Jan 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients referred to the participating centers for the treatment of symptomatic degenerative lesions of the knee, which meet the following inclusion criteria
Who may be able to join
- 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.
Who cannot join
- Patients with synovitis;
- BMI> 30;
- Allergy to collagen or calcium phosphate;
- Patients with neoplastic disease;
- Patients with metabolic disorders, thyroid diseases, immune system disorders.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Andrea Mocci
Bari, Bari, 70124
Raul Zini
Cotignola, Ravenna, 48010
Maurizio Bellettato
Faenza, Ravenna, 48018
Luisangelo Sordo
Torino, Torino, 10132
About this study
Official title: Observational Studies, Prospective, Multicenter, to Evaluate the Effect of Treatment of Knee Osteochondral Lesions of Outerbridge 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.
Read the 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.
- Being tested
- knee surgery
- Keywords
- osteochondral defect of the knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee surgeryProcedure or surgery
Reparative, replacement or regenerative techniques, with or without associated osteotomy.
| Study group | Role | What they receive |
|---|---|---|
| knee surgery | Not described Receives: Procedure: knee surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post procedure
Secondary outcomes (4)
functional recovery at International Knee Documentation Committee(IKDC) knee Examination
Measured: 12 months
Physical performance at Tegner activity score
Measured: 12 months post surgery
functional activity on the Lysholm Knee Scale
Measured: 12 months post surgery
Tissue regeneration at magnetic resonance (MRI)
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lesion of Articular Cartilage of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ettore Sansavini Health Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raul Zini, MD, Study director, Maria Cecilia HospitalLuisangelo Sordo, MD, Principal investigator, MARIA PIA HOSPITALMaurizio Bellettato, MD, Principal investigator, SAN PIER DAMIANOAndrea Mocci, MD, Principal investigator, ANTHEA HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554878
- Sponsor's protocol ID
- ESREFO08
- Acronym
- LOGIC
- Status last verified
- May 2014
- First submitted
- 12 Mar 2012
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Studies, Prospective, Multicenter, to Evaluate the Effect of Treatment of Knee Osteochondral Lesions of Outerbridge Grade III-IV
- ClinicalTrials.gov ID
- NCT01554878
- Acronym / sponsor ID
- LOGIC / ESREFO08
- Keywords
- osteochondral defect of the knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ettore Sansavini Health Science FoundationUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| knee surgery | – | Procedure: knee surgery |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients referred to the participating centers for the treatment of symptomatic degenerative lesions of the knee, which meet the following inclusion criteria
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- Patients with synovitis;
- BMI> 30;
- Allergy to collagen or calcium phosphate;
- Patients with neoplastic disease;
- Patients with metabolic disorders, thyroid diseases, immune system disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| knee surgeryReparative, replacement or regenerative techniques, with or without associated osteotomy. | Procedure or surgery | knee surgery |
Primary outcome
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.
4 secondary outcomes
functional recovery at International Knee Documentation Committee(IKDC) knee Examination
Time frame: 12 months
Physical performance at Tegner activity score
Time frame: 12 months post surgery
functional activity on the Lysholm Knee Scale
Time frame: 12 months post surgery
Tissue regeneration at magnetic resonance (MRI)
Time frame: 12 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul Zini, MD study director
Maria Cecilia Hospital
Luisangelo Sordo, MD principal investigator
MARIA PIA HOSPITAL
Maurizio Bellettato, MD principal investigator
SAN PIER DAMIANO
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lesion of Articular Cartilage of Knee, run by Ettore Sansavini Health Science Foundation at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.