Synthetic versus autologous reconstruction of the medial patellofemoral ligament

Not Applicable

Completed

• Conditions: Recurrent patellar instability with MRI-proven MPFL injury; Musculoskeletal Diseases

• Registration Number: ISRCTN16657952
• Lead Sponsor: Western Health and Social Care Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-03
• Study Completion: 2022-01-31
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Revision surgery<br> 2. Recurrent dislocation<br> The timepoints for revision and recurrent dislocation are not specified, as these will be defined by these events occurring in the patient after surgery.<br>