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This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.
Progression of knee cartilage degenerative changes leads to necessary total knee arthroplasty in future, which is the most popular procedure for treating OA. HTO applied at early stages of osteoarthritis allow slow down cartilage degeneration process, but the choice of performed surgery depends on surgeons personal assessment. Patellofemoral Pain Syndrome often occurs with knee arthritis. Antero-medialisation of tibial tubercle is frequent procedures for patella maltracking. So far, both, HTO and Fulkerson osteotomy was performed separately, even if patient have symptoms from patellofemoral joint and OA. The investigators believe that simultaneously surgery of HTO and fulkerson Osteotomy provides better outcomes and significantly slow down knee degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTO and Fulkerson | Active Comparator | High Tibial Osteotomy with Antero-medialisation of Tibial Tubercle |
|
| HTO | Sham Comparator | Descending Hight Tibial Osteotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Tibial Osteotomy | Procedure | Surgery procedure - High Tibial Osteotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomechanics MRI | Patellofemoral Joints Biomechanics improvement measured | 1 year |
| Biomechanics MRI | Patellofemoral Joints Biomechanics improvement measured | 2 years |
| Biomechanics X-ray | Patellofemoral Joints Biomechanics improvement measured | 12 weeks |
| Biomechanics X-ray | Patellofemoral Joints Biomechanics improvement measured | 6 months |
| Biomechanics X-ray | Patellofemoral Joints Biomechanics improvement measured | 12 months |
| Biomechanics X-ray | Patellofemoral Joints Biomechanics improvement measured | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 12 weeks |
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafał Kamiński, MD PhD | Contact | +48227794031 | 469 | kaminski@spskgruca.pl |
| 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 | Recruiting | Otwock | Masovian Voivodeship | 05-400 | Poland |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| KOOS | Knee Injury and Osteoarthritis Outcome Score | 12 months |
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 24 months |
| IKDC | International Knee Documentation Committee | 12 weeks |
| IKDC | International Knee Documentation Committee | 6 months |
| IKDC | International Knee Documentation Committee | 12 months, |
| IKDC | International Knee Documentation Committee | 24 months |
| Tegner Lysholm | Tegner Lysholm Knee Scoring Scale | 12 weeks, |
| Tegner Lysholm | Tegner Lysholm Knee Scoring Scale | 6 months |
| Tegner Lysholm | Tegner Lysholm Knee Scoring Scale | 12 months |
| Tegner Lysholm | Tegner Lysholm Knee Scoring Scale | 24 months |
| SF-36 | The Short Form (36) Health Survey | 12 weeks |
| SF-36 | The Short Form (36) Health Survey | 6 months |
| SF-36 | The Short Form (36) Health Survey | 12 months |
| SF-36 | The Short Form (36) Health Survey | 24 months |
| VAS | Pain Visual Analog Scale | 12 week |
| VAS | Pain Visual Analog Scale | 6 months |
| VAS | Pain Visual Analog Scale | 12 months |
| VAS | Pain Visual Analog Scale | 24 months |
| Blood test | CRP, IL-6, CTx | 2nd day |
| Blood test | CRP, IL-6, CTx | 6 weeks |
|