Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2025-12-16 @ 9:54 AM
Study NCT ID:
NCT06169800
Status:
None
Last Update Posted:
2025-10-22 00:00:00
First Post:
2023-12-05 00:00:00
Brief Title:
Biologic Augment of the Medial Patellofemoral Ligament Following Primary Lateral Patellofemoral Dislocation (BioPPD)
Sponsor:
Banff Sport Medicine Foundation
Organization:
Banff Sport Medicine Foundation
Study Overview
Official Title:
A Pilot Study to Evaluate the Effectiveness of a Biologic Augment of the Medial Patellofemoral Ligament to Reduce Recurrence After a Primary Lateral Patellofemoral Dislocation (BioPPD)
Status:
None
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BioPPD
Brief Summary:
This study aims to determine the ability of MPFL repair augmented with Biobrace® to decrease the re-dislocation rate after a primary patellofemoral dislocation. The null hypothesis is that there will be no difference in re-dislocation rate 2 years after surgical stabilization with Biobrace® compared to the natural history of patellar instability.
Patellofemoral instability is a well-recognized and common knee joint injury. Studies reporting the natural history after a first-time patellofemoral dislocation have reported a recurrence rate ranging from 10-80%. Recurrence varies depending on the unique pathoanatomic risk factors of each patient. Risk factors related to recurrence after a first-time dislocation include open growth plates, age at first dislocation, trochlear dysplasia, increased tibial tubercle - trochlear groove (TT-TG) distance, contralateral dislocation, and patella alta. A recent systematic review and meta-analysis determined the redislocation rate in patients managed without surgery after a first-time dislocation was 30%.
The MPFL plays a critical role in the constraint of lateral translation of the patella, providing 50-60% of the soft tissue restraint in early flexion before the patella engages in the trochlear groove. Essentially, the MPFL guides and holds the patella in the trochlear groove, especially between 0-45 degrees of flexion. MPFL insufficiency is present in as many as 90% of acute patellar dislocations and up to 100% of recurrent cases. The traditional non-operative treatment for a first-time dislocation has been to splint the knee in extension, which may prevent further dislocation but does not reduce the patella in the trochlear groove so that the medial soft tissue can heal in an anatomic position.
Multiple studies have investigated operative and non-operative treatments that aim to reduce recurrence after a first-time patellofemoral dislocation. To date, the type of knee immobilization has not been demonstrated to influence the recurrence rate. Operative management has been investigated compared to traditional non-operative treatment. A systematic review tabulated 15 studies comparing MPFL repair to non-operative management demonstrated decreased re-dislocation rates and decreased knee pain in those with surgical repair. Liebensteiner et al. reviewed studies with level 1 or 2 evidence and concluded that there are mixed results and that consensus on the ideal management after a first-time dislocation is still unclear. Despite these published results, surgical treatment after a first-time dislocation has not found widespread acceptance.
Further trials have compared MPFL repair to MPFL reconstruction. Bitar et al. conducted a study of MPFL reconstruction compared to non-operative management using the current a la carte indications for isolated MPFL reconstruction. These authors concluded that MPFL reconstruction was superior for preventing re-dislocation of the patella. Another recent retrospective review of 76 patients with an osteochondral lesion followed for 2 years compared MPFL-R to MPFL repair or no treatment. This study determined that completing an MPFL-R at index surgery resulted in a 5-fold reduction in recurrent instability.
Synthetic products can be used as a graft to reconstruct an MPFL. A systematic review has reported good results at a minimum of 2 years post-operative. Most synthetic products available today to augment or enhance the repair of ligaments are designed to address only one of two failure mechanisms: they either add mechanical strength without biological healing or aid in remodelling the underlying tendon tissue without providing mechanical strength during surgical repair. The inability of current devices to both strengthen the repair and create a favourable healing environment for cellular infiltration and tissue growth has led to further innovation and the development of the Biobrace® implant by Biorez. The Biobrace® implant is intended for use in general surgical procedures to reinforce soft tissue where weakness exists. The Biobrace® implant is also designed to reinforce soft tissues repaired by suture or suture anchors during tendon or ligament repair surgery.
Patellofemoral instability is a well-recognized and common knee joint injury. Studies reporting the natural history after a first-time patellofemoral dislocation have reported a recurrence rate ranging from 10-80%. Recurrence varies depending on the unique pathoanatomic risk factors of each patient. Risk factors related to recurrence after a first-time dislocation include open growth plates, age at first dislocation, trochlear dysplasia, increased tibial tubercle - trochlear groove (TT-TG) distance, contralateral dislocation, and patella alta. A recent systematic review and meta-analysis determined the redislocation rate in patients managed without surgery after a first-time dislocation was 30%.
The MPFL plays a critical role in the constraint of lateral translation of the patella, providing 50-60% of the soft tissue restraint in early flexion before the patella engages in the trochlear groove. Essentially, the MPFL guides and holds the patella in the trochlear groove, especially between 0-45 degrees of flexion. MPFL insufficiency is present in as many as 90% of acute patellar dislocations and up to 100% of recurrent cases. The traditional non-operative treatment for a first-time dislocation has been to splint the knee in extension, which may prevent further dislocation but does not reduce the patella in the trochlear groove so that the medial soft tissue can heal in an anatomic position.
Multiple studies have investigated operative and non-operative treatments that aim to reduce recurrence after a first-time patellofemoral dislocation. To date, the type of knee immobilization has not been demonstrated to influence the recurrence rate. Operative management has been investigated compared to traditional non-operative treatment. A systematic review tabulated 15 studies comparing MPFL repair to non-operative management demonstrated decreased re-dislocation rates and decreased knee pain in those with surgical repair. Liebensteiner et al. reviewed studies with level 1 or 2 evidence and concluded that there are mixed results and that consensus on the ideal management after a first-time dislocation is still unclear. Despite these published results, surgical treatment after a first-time dislocation has not found widespread acceptance.
Further trials have compared MPFL repair to MPFL reconstruction. Bitar et al. conducted a study of MPFL reconstruction compared to non-operative management using the current a la carte indications for isolated MPFL reconstruction. These authors concluded that MPFL reconstruction was superior for preventing re-dislocation of the patella. Another recent retrospective review of 76 patients with an osteochondral lesion followed for 2 years compared MPFL-R to MPFL repair or no treatment. This study determined that completing an MPFL-R at index surgery resulted in a 5-fold reduction in recurrent instability.
Synthetic products can be used as a graft to reconstruct an MPFL. A systematic review has reported good results at a minimum of 2 years post-operative. Most synthetic products available today to augment or enhance the repair of ligaments are designed to address only one of two failure mechanisms: they either add mechanical strength without biological healing or aid in remodelling the underlying tendon tissue without providing mechanical strength during surgical repair. The inability of current devices to both strengthen the repair and create a favourable healing environment for cellular infiltration and tissue growth has led to further innovation and the development of the Biobrace® implant by Biorez. The Biobrace® implant is intended for use in general surgical procedures to reinforce soft tissue where weakness exists. The Biobrace® implant is also designed to reinforce soft tissues repaired by suture or suture anchors during tendon or ligament repair surgery.
Detailed Description:
This study aims to determine the ability of MPFL repair augmented with Biobrace to decrease the re-dislocation rate after a primary patellofemoral dislocation The null hypothesis is that there will be no difference in re-dislocation rate 2 years after surgical stabilization with Biobrace compared to the natural history of patellar instability
Patellofemoral instability is a well-recognized and common knee joint injury Studies reporting the natural history after a first-time patellofemoral dislocation have reported a recurrence rate ranging from 10-80 Recurrence varies depending on the unique pathoanatomic risk factors of each patient Risk factors related to recurrence after a first-time dislocation include open growth plates age at first dislocation trochlear dysplasia increased tibial tubercle - trochlear groove TT-TG distance contralateral dislocation and patella alta A recent systematic review and meta-analysis determined the redislocation rate in patients managed without surgery after a first-time dislocation was 30
The MPFL plays a critical role in the constraint of lateral translation of the patella providing 50-60 of the soft tissue restraint in early flexion before the patella engages in the trochlear groove Essentially the MPFL guides and holds the patella in the trochlear groove especially between 0-45 degrees of flexion MPFL insufficiency is present in as many as 90 of acute patellar dislocations and up to 100 of recurrent cases The traditional non-operative treatment for a first-time dislocation has been to splint the knee in extension which may prevent further dislocation but does not reduce the patella in the trochlear groove so that the medial soft tissue can heal in an anatomic position
Multiple studies have investigated operative and non-operative treatments that aim to reduce recurrence after a first-time patellofemoral dislocation To date the type of knee immobilization has not been demonstrated to influence the recurrence rate Operative management has been investigated compared to traditional non-operative treatment A systematic review tabulated 15 studies comparing MPFL repair to non-operative management demonstrated decreased re-dislocation rates and decreased knee pain in those with surgical repair Liebensteiner et al reviewed studies with level 1 or 2 evidence and concluded that there are mixed results and that consensus on the ideal management after a first-time dislocation is still unclear Despite these published results surgical treatment after a first-time dislocation has not found widespread acceptance
Further trials have compared MPFL repair to MPFL reconstruction Bitar et al conducted a study of MPFL reconstruction compared to non-operative management using the current a la carte indications for isolated MPFL reconstruction These authors concluded that MPFL reconstruction was superior for preventing re-dislocation of the patella Another recent retrospective review of 76 patients with an osteochondral lesion followed for 2 years compared MPFL-R to MPFL repair or no treatment This study determined that completing an MPFL-R at index surgery resulted in a 5-fold reduction in recurrent instability
Synthetic products can be used as a graft to reconstruct an MPFL A systematic review has reported good results at a minimum of 2 years post-operative Most synthetic products available today to augment or enhance the repair of ligaments are designed to address only one of two failure mechanisms they either add mechanical strength without biological healing or aid in remodelling the underlying tendon tissue without providing mechanical strength during surgical repair The inability of current devices to both strengthen the repair and create a favourable healing environment for cellular infiltration and tissue growth has led to further innovation and the development of the Biobrace implant by Biorez The Biobrace implant is intended for use in general surgical procedures to reinforce soft tissue where weakness exists The Biobrace implant is also designed to reinforce soft tissues repaired by suture or suture anchors during tendon or ligament repair surgery
Patellofemoral instability is a well-recognized and common knee joint injury Studies reporting the natural history after a first-time patellofemoral dislocation have reported a recurrence rate ranging from 10-80 Recurrence varies depending on the unique pathoanatomic risk factors of each patient Risk factors related to recurrence after a first-time dislocation include open growth plates age at first dislocation trochlear dysplasia increased tibial tubercle - trochlear groove TT-TG distance contralateral dislocation and patella alta A recent systematic review and meta-analysis determined the redislocation rate in patients managed without surgery after a first-time dislocation was 30
The MPFL plays a critical role in the constraint of lateral translation of the patella providing 50-60 of the soft tissue restraint in early flexion before the patella engages in the trochlear groove Essentially the MPFL guides and holds the patella in the trochlear groove especially between 0-45 degrees of flexion MPFL insufficiency is present in as many as 90 of acute patellar dislocations and up to 100 of recurrent cases The traditional non-operative treatment for a first-time dislocation has been to splint the knee in extension which may prevent further dislocation but does not reduce the patella in the trochlear groove so that the medial soft tissue can heal in an anatomic position
Multiple studies have investigated operative and non-operative treatments that aim to reduce recurrence after a first-time patellofemoral dislocation To date the type of knee immobilization has not been demonstrated to influence the recurrence rate Operative management has been investigated compared to traditional non-operative treatment A systematic review tabulated 15 studies comparing MPFL repair to non-operative management demonstrated decreased re-dislocation rates and decreased knee pain in those with surgical repair Liebensteiner et al reviewed studies with level 1 or 2 evidence and concluded that there are mixed results and that consensus on the ideal management after a first-time dislocation is still unclear Despite these published results surgical treatment after a first-time dislocation has not found widespread acceptance
Further trials have compared MPFL repair to MPFL reconstruction Bitar et al conducted a study of MPFL reconstruction compared to non-operative management using the current a la carte indications for isolated MPFL reconstruction These authors concluded that MPFL reconstruction was superior for preventing re-dislocation of the patella Another recent retrospective review of 76 patients with an osteochondral lesion followed for 2 years compared MPFL-R to MPFL repair or no treatment This study determined that completing an MPFL-R at index surgery resulted in a 5-fold reduction in recurrent instability
Synthetic products can be used as a graft to reconstruct an MPFL A systematic review has reported good results at a minimum of 2 years post-operative Most synthetic products available today to augment or enhance the repair of ligaments are designed to address only one of two failure mechanisms they either add mechanical strength without biological healing or aid in remodelling the underlying tendon tissue without providing mechanical strength during surgical repair The inability of current devices to both strengthen the repair and create a favourable healing environment for cellular infiltration and tissue growth has led to further innovation and the development of the Biobrace implant by Biorez The Biobrace implant is intended for use in general surgical procedures to reinforce soft tissue where weakness exists The Biobrace implant is also designed to reinforce soft tissues repaired by suture or suture anchors during tendon or ligament repair surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None