ISRCTN16657952已完成未知
Synthetic versus autologous reconstruction (Syn-VAR) study for recurrent patellar instability: a prospective randomised pilot study
Western Health and Social Care Trust0 个研究点目标入组 20 人开始时间: 2017年3月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29724252 protocol Poster results see attached file ISRCTN16657952_POSTER.pptx (added 14/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 29/01/2018:
- •1. Aged 14-25 years
- •2. Confirmed medial patellofemoral ligament rupture on MRI
- •3. Pre-operative AP, lateral and skyline radiographs
- •4. Unilateral or bilateral symptoms
- •5. Clinical signs of patellar instabiltity
- •6. Closed proximal tibial physes
- •7. Only patients with 2 or more dislocations will be considered for inclusion
- •Previous inclusion criteria from 08/09/2017 to 29/01/2018:
- •1. Aged 14-25 years
- •2. Confirmed medial patellofemoral ligament rupture on MRI
- •3. Pre-operative AP, lateral and skyline radiographs
- •4. Unilateral or bilateral symptoms
- •5. Clinical signs of patellar instabiltity
- •6. Closed proximal tibial physes
- •Original inclusion criteria:
- •1. Aged 14-25 years
- •2. Confirmed medial patellofemoral ligament rupture on MRI
- •3. Pre-operative AP, lateral and skyline radiographs
- •4. Unilateral or bilateral symptoms
排除标准
- •Current exclusion criteria as of 14/02/2018:
- •1. Patients requiring bony transfer procedures (e.g., tibial tuberosity transfer)
- •2. Patients requiring a lateral release or Z-lengthening of the lateral structures
- •3. Patients with lateral compression signs on the skyline radiographs
- •4. Patients with confirmed multi-ligamentous knee injury
- •5. Patients with confirmed osteochondral lesions on MRI or plain radiograph pre-operatively
- •6. Patients who have previously underwent surgery
- •7. Abnormal hip or hindfoot pathology
- •8. Excessive femoral anteversion (>30 degrees) and/or excessive external tibial torsion (>40 degrees)
- •9. Excessive coronal plane deformity
- •10. Dejour grade C/D trochlear dysplasia
- •11. Excessive patellar tilt as measured by the Angle or Laurin and Fulkerson Angle methods.
- •12. Skeletally immature patients
- •13. Eastablish radiological changes of arthritis
- •14. Patients with confirmed hypersensitivity to synthetic graft material
- •15. A TT-TG distance >20mm on MRI/CT
- •Previous exclusion criteria from 08/09/2017 to 14/02/2018:
- •1. Patients requiring bony transfer procedures (e.g., tibial tuberosity transfer)
- •2. Patients requiring a lateral release or Z-lengthening of the lateral structures
- •3. Patients with lateral compression signs on the skyline radiographs
- •4. Patients with confirmed multi-ligamentous knee injury
- •5. Patients with confirmed osteochondral lesions on MRI or plain radiograph pre-operatively
- •6. Patients who have previously underwent surgery
- •7. Abnormal hip or hindfoot pathology
- •8. Excessive femoral anteversion (>30 degrees) and/or excessive external tibial torsion (>40 degrees)
- •9. Excessive coronal plane deformity
- •10. Dejour grade D trochlear dysplasia
- •11. Excessive patellar tilt as measured by the Angle or Laurin and Fulkerson Angle methods.
- •12. Skeletally immature patients
- •13. Eastablish radiological changes of arthritis
- •14. Patients with confirmed hypersensitivity to synthetic graft material
- •15. Insall-Salvati >1.2, Gaton Dechamp <1.3 or TT-TG >20mm
- •Original exclusion criteria:
- •1. Patients requring bony transfer procedures (e.g., tibial tuberosity transfer)
- •2. Patients requiring a lateral release or Z-lengthening of the lateral structures
- •3. Patients with lateral compression signs on the skyline radiographs
- •4. Patients with confirmed multi-ligamentous knee injury
- •5. Patients with confirmed osteochondral lesions on MRI or plain radiograph pre-operatively
- •6. Patients who have previously underwent surgery
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