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| Name | Class |
|---|---|
| Rambam Health Care Campus | OTHER |
| Hadassah Medical Organization | OTHER |
| Assaf-Harofeh Medical Center | OTHER_GOV |
| Soroka University Medical Center |
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The purpose of this study is to determine whether medial patellofemoral ligament reconstruction results in superior functional outcomes compared to medial retinacular plication surgery in cases of recurrent patellar instability.
Patients with recurrent lateral patellar instability will be assigned to undergo one of two surgical approaches aimed to prevent recurrent patellar instability and result in improvement in function. One surgical approach will be medial retinacular plication with multiple stitches while the other surgical approach will include medial patellofemoral ligament reconstruction using a hamstring tendon graft. Prior to surgery, and then during follow-up after surgery as well as at the completion of minimum two years follow-up after surgery, patients will be asked to complete subjective functional questionaires that will rate their knee function, and to undergo detailed physical examination and objective functional tests that will quantify the success of surgery. The outcomes of the surgical treatment options will be compared to determine whether medial patellofemoral ligament reconstruction results in superior function and patient subjective satisfaction compared to medial retinacular plication only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medial plication | Other | Patient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication |
|
| MPFL reconstruction | Other | Patient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical treatment for recurrent patellar instability | Procedure | Either medial plication or MPFL reconstructuion surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kujala knee outcome score | A validated international outcome score that evaluates knee functional outcome in relation to patellofemoral symptoms | Between two and five years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee subjective outcome score | A validated international outcome score that evaluates general knee functional outcome | Between two and five years after surgery |
| Tenger activity level score |
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Inclusion Criteria:
Imaging criteria include:
Exclusion Criteria:
Imaging criteria include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| IFTACH HETSRONI, M.D. | Contact | 972-9-747 | 1182 | iftach.hetsroni@clalit.org.il |
| DROR LINDNER, M.D. | Contact | 972-8-977 | 9443 | Drorlindner@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| IFTACH HETSRONI, M.D. | Meir Medical Center | Principal Investigator |
| DROR LINDNER, M.D. | Assaf-Harofeh Medical Center | Principal Investigator |
| IDAN ILSAR, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | 44281 | Israel |
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| ID | Term |
|---|---|
| C566816 | Patella, Familial Recurrent Dislocation Of |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER |
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A validated international outcome score that evaluates highest level of sports activity
| Between two and five years after surgery |
| Marx activity level score | A validated international outcome score that evaluates highest level of sports activity | Between two and five years after surgery |
| Visual Analogue Scale | A validated international scale that evaluates level of pain | Between two and five years after surgery |
| Single hop test | Evaluates limb asymmetry index between operated and nonoperated limbs during a single legged hop for distance | Between two and five years after surgery |
| Side-to-side hop test | Evaluates limb asymmetry index between operated and nonoperated limbs performing side to side repetaed hops during 30 seconds | Between two and five years after surgery |
| Patellar apprehension test | Evaluates normal patellar tracking and patient's feeling of subjective comfort while the examiner apply a provocative force that translates the patella lateraly | Between two and five years after surgery |
| Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavage | Infection of the surgical site as a severe complication of surgery, requirng antibiotics with or without joint lavage | Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month |
| Hadassah Medical Organization |
| Principal Investigator |
| MAZEN FALAH, M.D. | Rambam Health Care Campus | Principal Investigator |
| NASSIM ALKRINAWI, M.D. | Soroka University Medical Center | Principal Investigator |