Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639308
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A well-established protocol for the treatment or augmentation a wide range of Achilles disorders including chronic Achilles tendon AT rupture Achilles insertional tendinopathy Haglund syndrome and among others is a Flexor hallucis longus FHL tendon transfer 1-4
Long incisions are required for open surgical procedures which increase the risk of skin breakdown and wound infection These factors have contributed to the increased use of endoscopy in the surgical treatment of different Achilles pathologies Compared to open methods endoscopic techniques provided the advantage of managing pathology with a low risk of soft-tissue complications4-7
It has been recommended to use an FHL transfer 8-10 Its anatomic proximity prevents iatrogenic lesions of the neurovascular bundle it fires in phase with the gastrocnemius-soleus complex it is a stronger plantar flexor and its axis of contractile force more closely looks similar to that of the AT It is plantar flexion strength reinforcement which is almost always compromised with fascial advancement alone11 Regarding the nature of the ATs vascularization the FHL muscle belly reaches distally into its avascular zone which allows the repaired AT to be recruitment of an increased blood supply Moreover by moving muscles that perform the same function FHL transfer preserves the ankles natural muscular balance 8 A recent study using magnetic resonance imaging evaluation revealed that in 60 of patients the FHL tendon had fully integrated and in 80 of patients there was hypertrophy of the tendon above 15
This study tends to compare the outcomes of both open and endoscopic FHL transfer in different parameters like functional outcome wound complication and accelerated rehabilitation
This is a Prospective randomized control trial The study will be conducted on 30 patients complaining of chronic Achilles tendon rupture Achilles insertional tendinopathy Haglund syndrome planned for FHL transfer in Assiut university hospital Patients will be randomized to two groups one group endoscopic FHL will be conducted in other hand second group open FHL will be conducted
The PICOT algorithm was preliminarily pointed out
P Problem Different Achilles disorders such as chronic Achilles tendon AT rupture Achilles insertional tendinopathy Haglund syndrome and among others
I Intervention Endoscopic FHL Transfer
C Comparison open FHL tendon transfers
O Outcomes Clinical outcomes complications and return to sport
T Timing 6 months of follow-up
Preoperative assessment
A- Detailed history and examination
Detailed history for patient complains and previous trauma or surgery
Physical examination for FHL AT any foot and ankle deformities functional Achilles pathology or ankle range-of-motion deficits
VAS score Achilles tendon Total Rupture Score - ATRS American Orthopaedic Foot Ankle Society AOFAS hindfoot score and ankle plantarflexion strength will be assessed preoperatively and at the latest follow-up minimum of 1 year after the procedure
Research outcome measures
a Primary main Functional outcome of endoscopic versus open FHL transfer in various TA pathology American Orthopaedic Foot Ankle Society AOFAS ankle-hindfoot score Achilles tendon Total Rupture Score - ATRS ankle plantarflexion strength
Secondary subsidiary
Wound complication skin dehiscence and infection rate
Expected time to complete return to sports activities or return to previous levels of activity
Accelerated rehabilitation
Long incisions are required for open surgical procedures which increase the risk of skin breakdown and wound infection These factors have contributed to the increased use of endoscopy in the surgical treatment of different Achilles pathologies Compared to open methods endoscopic techniques provided the advantage of managing pathology with a low risk of soft-tissue complications4-7
It has been recommended to use an FHL transfer 8-10 Its anatomic proximity prevents iatrogenic lesions of the neurovascular bundle it fires in phase with the gastrocnemius-soleus complex it is a stronger plantar flexor and its axis of contractile force more closely looks similar to that of the AT It is plantar flexion strength reinforcement which is almost always compromised with fascial advancement alone11 Regarding the nature of the ATs vascularization the FHL muscle belly reaches distally into its avascular zone which allows the repaired AT to be recruitment of an increased blood supply Moreover by moving muscles that perform the same function FHL transfer preserves the ankles natural muscular balance 8 A recent study using magnetic resonance imaging evaluation revealed that in 60 of patients the FHL tendon had fully integrated and in 80 of patients there was hypertrophy of the tendon above 15
This study tends to compare the outcomes of both open and endoscopic FHL transfer in different parameters like functional outcome wound complication and accelerated rehabilitation
This is a Prospective randomized control trial The study will be conducted on 30 patients complaining of chronic Achilles tendon rupture Achilles insertional tendinopathy Haglund syndrome planned for FHL transfer in Assiut university hospital Patients will be randomized to two groups one group endoscopic FHL will be conducted in other hand second group open FHL will be conducted
The PICOT algorithm was preliminarily pointed out
P Problem Different Achilles disorders such as chronic Achilles tendon AT rupture Achilles insertional tendinopathy Haglund syndrome and among others
I Intervention Endoscopic FHL Transfer
C Comparison open FHL tendon transfers
O Outcomes Clinical outcomes complications and return to sport
T Timing 6 months of follow-up
Preoperative assessment
A- Detailed history and examination
Detailed history for patient complains and previous trauma or surgery
Physical examination for FHL AT any foot and ankle deformities functional Achilles pathology or ankle range-of-motion deficits
VAS score Achilles tendon Total Rupture Score - ATRS American Orthopaedic Foot Ankle Society AOFAS hindfoot score and ankle plantarflexion strength will be assessed preoperatively and at the latest follow-up minimum of 1 year after the procedure
Research outcome measures
a Primary main Functional outcome of endoscopic versus open FHL transfer in various TA pathology American Orthopaedic Foot Ankle Society AOFAS ankle-hindfoot score Achilles tendon Total Rupture Score - ATRS ankle plantarflexion strength
Secondary subsidiary
Wound complication skin dehiscence and infection rate
Expected time to complete return to sports activities or return to previous levels of activity
Accelerated rehabilitation
Detailed Description:
It is research that will be applied on patients with tendon Achilles disorders and planned for a Flexor hallucis longus FHL tendon transfer to augment and strength planter flexion power of ankle Using endoscopic techniques provided the advantage of managing pathology with a low risk of soft-tissue complications and improve outcome
The study will be approved from Ethical and research committee of the faculty of medicine Asyut University
Type of the study This is a Prospective randomized control trial
Study Setting Department of Orthopaedic and trauma surgery Assiut university
Study subjects
1 Inclusion criteria
2 Chronic TA ruptures more than 6 weeks
3 Non-insertional TA tendinopathy with an injury greater than 50
4 Haglund deformity plus insertional Achilles tendinopathy IAT
5 Patients with major degenerative tendon tissues with acute Achilles tendon rupture
6 Acute Achilles tendon rupture in athletic patients
7 Failed conservative or operatively treated ruptures healed TA with both reduced function and significantly lengthening of the Achilles tendon after focused physiotherapy treatment has failed to restore function to a level evaluated as satisfactory by the patients
b Exclusion criteria h Malalignment or end-stage tibiotalar and subtalar joint osteoarthritis i The presence of FHL tendon pathology j Acute or chronic infection k Sever bone loss or defects Systemic immunodeficiency or chemotherapy c Sample Size Calculation
Sample size
Based on determining the main outcome variable the estimated minimum required sample size is 24 patients 12 patient in each group4
The sample was calculated using Gpower software 3192 based on the following assumptions
Main outcome variable is the difference between mean value of strength of planter flexion of ankle joint using the American ankle and foot functional score AOFAS
Based on clinical experience we expected to find large effect size difference 4between 2 groups Main statistical test is independent t-test to detect the difference between the 2 groups
Alpha 005 Power 080 Effect size 12
Preoperative assessment
A- Detailed history and examination
Detailed history for patient complains and previous trauma or surgery
Physical examination for FHL AT any foot and ankle deformities functional Achilles pathology or ankle range-of-motion deficits
VAS score Achilles tendon Total Rupture Score - ATRS American Orthopaedic Foot Ankle Society AOFAS hindfoot score and ankle plantarflexion strength will be assessed preoperatively and at the latest follow-up minimum of 1 year after the procedure
B- Radiological assessment
Plane X-ray for ankle and foot AP -Lateral - standing AP
MRI showing FHL TA pathology and other foot or ankle pathology
C- Surgical procedure
A-Endoscopic FHL tendon transfer
Patients will place in a prone position under spinal or general anaesthesia with a thigh tourniquet Hindfoot endoscopic portals posteromedial and posterolateral will be located at the same level of the fibular tip or slightly distal at both sides of the Achilles tendon with the aim to better vision and access to the insertional area of the Achilles tendon modified portals will be located slightly distal and anterior to the classical hindfoot endoscopic portals The posterolateral portal was used as the visualization portal and the posteromedial portal as the working portal A distal midline Achilles portal has been described and used for Haglund resection and introduction of bioabsorbable screw may be used in some cases
A standardized endoscopic technique will be performed A working area will be created when posterior soft tissue is debrided Anatomical structures of the posterior ankle should be identified The posterolateral aspect of the subtalar joint is first identified Next the scope and instruments will be redirected to the posterior area With the shaver in contact with the superior area of the calcaneus removal of the soft tissue and bursectomy is performed until the posterior calcaneal tubercle is visualized
After calcaneal bursectomy and with the ankle in plantarflexion the anterior surface of the AT and its insertional area could be observed
Endoscopic calcaneoplasty Haglund deformity can be resected with the instruments inserted through the posterolateral and posteromedial classic or modified hindfoot endoscopic portals The calcaneal ostectomy will be performed with the burr inserted through a distal midline Achilles portal Care should be taken to protect the AT The cutting end of the instrument should be directed toward the bone and away from the tendon Bone resection could be underestimated when endoscopically performed Radiological control is recommended to observe calcaneal ostectomy A Kirschner wire K-wire placed under radiological control can be used as a guide for the bone resection If any pathology of the tendon such as intra-tendinous calcification or insertional partial tendon tear is observed debridement of the pathological tissue can be performed with arthroscopic shaver
Endoscopic FHL tendon transfer The endoscopic FHL tendon transfer is usually performed with the scope introduced through the posterolateral portal and instruments through the posteromedial portal The FHL tendon must be identified during hindfoot working area creation The FHL tendon is the main hindfoot endoscopic landmark as the neurovascular tibial bundle is located medial to it First the calcaneoplasty is completed as described Next the FHL tendon is harvested The posterior fibulo-talocalcaneal ligament complex or Rouvière and Canela ligament is cut as proximal as possible in order to allow free movement of the FHL tendon and allows a straight FHL tendon trajectory to the most posterior aspect of the calcaneal bone
The FHL tendon is pierced with a suture passer and a lasso loop type suture is tied to provide traction on the tendon The foot is held in plantar flexion with the hallux flexed relaxing the flexor hallucis longus FHL and the traction suture is grasped and gently pulled allowing for as distal a tenotomy as possible Tenotomy is performed with arthroscopic scissors while the foot is maintained in the aforementioned position9 12
Once the tendon is cut it is pulled out through the posteromedial portal The tendon is grasped with a Krackow suture A high-resistance suture 0 or 2 is recommended Then the FHL tendon has to be introduced into a calcaneal tunnel and secured with a screw A half-tunnel is drilled in the most posterior and superior part of the calcaneus as close as possible to the AT A K-wire with an eyelet introduced through the posteromedial portal is used as guide for the drill Drilling direction should be from dorsal to plantar and centred at midpoint between medial to lateral The diameter of the tunnel depends on the measure of the FHL tendon diameter while the tunnel depth is at least 10 mm to 15 mm longer than the FHL tendon length obtained Once the tunnel is drilled suture is introduced into the eyelet of the K-wire By pushing out the K-wire from the plantar aspect the sutures are passed through the tunnel and by pulling the sutures the tendon is introduced into the tunnel If necessary the introduction of the FHL tendon into the tunnel can be helped with a probe Under direct endoscopic vision a nitinol wire is introduced into the tunnel through the posteromedial portal Finally with the ankle in plantarflexion the sutures are pulled to tight the FHL tendon and the tendon is secured with an interference screw of same size than the tunnel Advancement of the screw and a final endoscopic control is performed Incisions will be closed and a walker boot will be applied with heel wedge in order to keep 15 to 20 of plantarflexion
B- Open FHL transfer
The FHL tendon can be approached through the posterior longitudinal incision The FHL is confirmed by digital retraction of the tendon watching for flexion of the hallux Dissection of the FHL tendon is followed to the posterior talus and FHL tunnel remaining lateral to avoid the neurovascular bundle Release of the fibro-osseous tunnel along the posterior talus is necessary to gain length With the hallux and ankle plantar flexed the FHL tendon is transected as distally as possible The tendon is fixed to the calcaneus just anterior to the Achilles stump insertion by an interference screw
The study will be approved from Ethical and research committee of the faculty of medicine Asyut University
Type of the study This is a Prospective randomized control trial
Study Setting Department of Orthopaedic and trauma surgery Assiut university
Study subjects
1 Inclusion criteria
2 Chronic TA ruptures more than 6 weeks
3 Non-insertional TA tendinopathy with an injury greater than 50
4 Haglund deformity plus insertional Achilles tendinopathy IAT
5 Patients with major degenerative tendon tissues with acute Achilles tendon rupture
6 Acute Achilles tendon rupture in athletic patients
7 Failed conservative or operatively treated ruptures healed TA with both reduced function and significantly lengthening of the Achilles tendon after focused physiotherapy treatment has failed to restore function to a level evaluated as satisfactory by the patients
b Exclusion criteria h Malalignment or end-stage tibiotalar and subtalar joint osteoarthritis i The presence of FHL tendon pathology j Acute or chronic infection k Sever bone loss or defects Systemic immunodeficiency or chemotherapy c Sample Size Calculation
Sample size
Based on determining the main outcome variable the estimated minimum required sample size is 24 patients 12 patient in each group4
The sample was calculated using Gpower software 3192 based on the following assumptions
Main outcome variable is the difference between mean value of strength of planter flexion of ankle joint using the American ankle and foot functional score AOFAS
Based on clinical experience we expected to find large effect size difference 4between 2 groups Main statistical test is independent t-test to detect the difference between the 2 groups
Alpha 005 Power 080 Effect size 12
Preoperative assessment
A- Detailed history and examination
Detailed history for patient complains and previous trauma or surgery
Physical examination for FHL AT any foot and ankle deformities functional Achilles pathology or ankle range-of-motion deficits
VAS score Achilles tendon Total Rupture Score - ATRS American Orthopaedic Foot Ankle Society AOFAS hindfoot score and ankle plantarflexion strength will be assessed preoperatively and at the latest follow-up minimum of 1 year after the procedure
B- Radiological assessment
Plane X-ray for ankle and foot AP -Lateral - standing AP
MRI showing FHL TA pathology and other foot or ankle pathology
C- Surgical procedure
A-Endoscopic FHL tendon transfer
Patients will place in a prone position under spinal or general anaesthesia with a thigh tourniquet Hindfoot endoscopic portals posteromedial and posterolateral will be located at the same level of the fibular tip or slightly distal at both sides of the Achilles tendon with the aim to better vision and access to the insertional area of the Achilles tendon modified portals will be located slightly distal and anterior to the classical hindfoot endoscopic portals The posterolateral portal was used as the visualization portal and the posteromedial portal as the working portal A distal midline Achilles portal has been described and used for Haglund resection and introduction of bioabsorbable screw may be used in some cases
A standardized endoscopic technique will be performed A working area will be created when posterior soft tissue is debrided Anatomical structures of the posterior ankle should be identified The posterolateral aspect of the subtalar joint is first identified Next the scope and instruments will be redirected to the posterior area With the shaver in contact with the superior area of the calcaneus removal of the soft tissue and bursectomy is performed until the posterior calcaneal tubercle is visualized
After calcaneal bursectomy and with the ankle in plantarflexion the anterior surface of the AT and its insertional area could be observed
Endoscopic calcaneoplasty Haglund deformity can be resected with the instruments inserted through the posterolateral and posteromedial classic or modified hindfoot endoscopic portals The calcaneal ostectomy will be performed with the burr inserted through a distal midline Achilles portal Care should be taken to protect the AT The cutting end of the instrument should be directed toward the bone and away from the tendon Bone resection could be underestimated when endoscopically performed Radiological control is recommended to observe calcaneal ostectomy A Kirschner wire K-wire placed under radiological control can be used as a guide for the bone resection If any pathology of the tendon such as intra-tendinous calcification or insertional partial tendon tear is observed debridement of the pathological tissue can be performed with arthroscopic shaver
Endoscopic FHL tendon transfer The endoscopic FHL tendon transfer is usually performed with the scope introduced through the posterolateral portal and instruments through the posteromedial portal The FHL tendon must be identified during hindfoot working area creation The FHL tendon is the main hindfoot endoscopic landmark as the neurovascular tibial bundle is located medial to it First the calcaneoplasty is completed as described Next the FHL tendon is harvested The posterior fibulo-talocalcaneal ligament complex or Rouvière and Canela ligament is cut as proximal as possible in order to allow free movement of the FHL tendon and allows a straight FHL tendon trajectory to the most posterior aspect of the calcaneal bone
The FHL tendon is pierced with a suture passer and a lasso loop type suture is tied to provide traction on the tendon The foot is held in plantar flexion with the hallux flexed relaxing the flexor hallucis longus FHL and the traction suture is grasped and gently pulled allowing for as distal a tenotomy as possible Tenotomy is performed with arthroscopic scissors while the foot is maintained in the aforementioned position9 12
Once the tendon is cut it is pulled out through the posteromedial portal The tendon is grasped with a Krackow suture A high-resistance suture 0 or 2 is recommended Then the FHL tendon has to be introduced into a calcaneal tunnel and secured with a screw A half-tunnel is drilled in the most posterior and superior part of the calcaneus as close as possible to the AT A K-wire with an eyelet introduced through the posteromedial portal is used as guide for the drill Drilling direction should be from dorsal to plantar and centred at midpoint between medial to lateral The diameter of the tunnel depends on the measure of the FHL tendon diameter while the tunnel depth is at least 10 mm to 15 mm longer than the FHL tendon length obtained Once the tunnel is drilled suture is introduced into the eyelet of the K-wire By pushing out the K-wire from the plantar aspect the sutures are passed through the tunnel and by pulling the sutures the tendon is introduced into the tunnel If necessary the introduction of the FHL tendon into the tunnel can be helped with a probe Under direct endoscopic vision a nitinol wire is introduced into the tunnel through the posteromedial portal Finally with the ankle in plantarflexion the sutures are pulled to tight the FHL tendon and the tendon is secured with an interference screw of same size than the tunnel Advancement of the screw and a final endoscopic control is performed Incisions will be closed and a walker boot will be applied with heel wedge in order to keep 15 to 20 of plantarflexion
B- Open FHL transfer
The FHL tendon can be approached through the posterior longitudinal incision The FHL is confirmed by digital retraction of the tendon watching for flexion of the hallux Dissection of the FHL tendon is followed to the posterior talus and FHL tunnel remaining lateral to avoid the neurovascular bundle Release of the fibro-osseous tunnel along the posterior talus is necessary to gain length With the hallux and ankle plantar flexed the FHL tendon is transected as distally as possible The tendon is fixed to the calcaneus just anterior to the Achilles stump insertion by an interference screw
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None