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This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Results of this study will help ascertain whether platelet rich plasma may improve meniscal healing rates.
The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. The investigators believe that augmentation with platelet rich plasma as prolotherapy ill induce healing without the need for arthroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trephination with placebo | Placebo Comparator | meniscal repair with trephination and placebo |
|
| trephination with platelet rich plasma | Experimental | meniscal repair with trephination and platelet rich plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trephination with placebo | Biological | trephination under US guidance and placebo injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of meniscal healing by MR scanning | The primary outcome measures will be assessment of meniscal healing integrity by MR scanning | by 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | Pain Visual Analog Scale. | 12 weeks, 6months, 1year post procedure |
| Knee injury and Osteoarthritis Outcome Score scale | Knee injury and Osteoarthritis Outcome Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafal Kaminski | PCME, Otwock, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital | Otwock | Masovian Voivodeship | 05-400 | Poland |
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| ID | Term |
|---|---|
| D014207 | Trephining |
| ID | Term |
|---|---|
| D003399 | Craniotomy |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| trephination with platelet rich plasma | Biological | trephination under US guidance and platelet rich plasma injection |
|
| 12 weeks, 6months, 1year post procedure |
| International Knee Documentation Committee - Subjective Knee Evaluation Form | International Knee Documentation Committee - Subjective Knee Evaluation Form | 12 weeks, 6months, 1year post procedure |