Recurrent patellar instability with MRI-proven MPFL injury Musculoskeletal Diseases
Conditions
Interventions
Patients will be randomised to receive either:
1. MPFL reconstruction with autologous hamstring graft (h-MPFL)
2. Synthetic woven ligament (s-MPFL)
Both are in combination with VMO advancement. Once r
Sponsors
Western Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcomes, measured using the Tegner activity scale, Lysholm Score and the Banff Patellar Instability Index Score, pre-operatively followed by post-operative checks at 6 weeks, and then again at 3/6/12/24 months post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Revision surgery 2. Recurrent dislocation The timepoints for revision and recurrent dislocation are not specified, as these will be defined by these events occurring in the patient after surgery. | — |
Countries
Northern Ireland, United Kingdom
Outcome results
None listed