Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505525
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-03
Brief Title:
Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction Prospective Multicenter Randomized Clinical Trial With Hamstring Autograft
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Abstract
Introduction Autologous hamstring tendons are the most commonly used grafts in ACL reconstruction worldwide There are several ways to prepare the graft using these tendons One can prioritize increasing the diameter of an isolated intra-articular graft or alternatively using one graft limb as an extra-articular reinforcement via the anterolateral ligament ALL reconstruction with both options aiming to reduce the re-rupture rate relative to traditional quadrupled hamstring grafts
Objective To compare through a prospective and randomized clinical trial intra and extra-articular ACL reconstruction with ALL using hamstring autograft versus isolated anatomical ACL reconstruction using quintuple or sextuple hamstring autograft
Methods 146 patients will be randomized into two groups of 20 patients Patients included in the study will be evaluated preoperatively and after surgery at 3 6 9 12 and 24 months postoperatively The primary outcomes will be clinical failure rate and graft rerupture rate Secondary outcomes will include functional capacity assessed through IKDC Lysholm KOOS and Tegner scores pain using the VAS as well as stability assessed by digital rolimeter and objective IKDC Kinesiophobia and anxiety will be measured using the Tampa scale and Anxiety and Depression scale
Keywords Rupture Anterior Cruciate Ligament Anterior Cruciate Ligament Reconstruction
Introduction Autologous hamstring tendons are the most commonly used grafts in ACL reconstruction worldwide There are several ways to prepare the graft using these tendons One can prioritize increasing the diameter of an isolated intra-articular graft or alternatively using one graft limb as an extra-articular reinforcement via the anterolateral ligament ALL reconstruction with both options aiming to reduce the re-rupture rate relative to traditional quadrupled hamstring grafts
Objective To compare through a prospective and randomized clinical trial intra and extra-articular ACL reconstruction with ALL using hamstring autograft versus isolated anatomical ACL reconstruction using quintuple or sextuple hamstring autograft
Methods 146 patients will be randomized into two groups of 20 patients Patients included in the study will be evaluated preoperatively and after surgery at 3 6 9 12 and 24 months postoperatively The primary outcomes will be clinical failure rate and graft rerupture rate Secondary outcomes will include functional capacity assessed through IKDC Lysholm KOOS and Tegner scores pain using the VAS as well as stability assessed by digital rolimeter and objective IKDC Kinesiophobia and anxiety will be measured using the Tampa scale and Anxiety and Depression scale
Keywords Rupture Anterior Cruciate Ligament Anterior Cruciate Ligament Reconstruction
Detailed Description:
1 Introduction Arthroscopic reconstruction of the anterior cruciate ligament ACL is a well-established procedure known for its superiority over non-surgical treatment of this injury However failure rates following ACL reconstruction can vary from 3-6 in some patient cohorts up to 40 in patients at increased risk of re-injury Hamstring autograft are the most commonly used for ACL reconstruction Considering that the final graft diameter inferior to 8mm is associated to increased failure rate and that increased intra-articular diameter is considered a protective factor the preparation of hamstring autografts influences the final outcome Historically used quadrupled hamstring grafts have been progressively replaced in recent years by quintupled or sextupled graft configurations in order to increase final graft diameter
However instead of using configurations that prioritize increasing the final diameter of hamstring autografts ACL reconstruction associated with extra-articular reconstruction of the anterolateral ligament ALL may be performed using a portion of the gracilis prioritizing the reconstruction of the ALL rather than increasing the intra-articular graft diameter The association of the ALL serves two main functions to decrease rotational instability which can reach up to 40 in high-risk patients and to mechanically protect the graft
In a comparative analysis pairing patients with similar characteristics ACL ALL reconstruction showed significantly lower rerupture rate compared to isolated ACL reconstruction 35 versus 174 In another comparative analysis also pairing patients for similarity isolated ACL reconstruction with bone-patellar tendon-bone BTB autograft showed a 3x higher risk of rerupture compared to ACL ALL reconstruction with hamstring autografts
Thus the investigators hypothesize that extra-articular reinforcement with ALL reconstruction associated with anatomical ACL reconstruction with hamstring autograft may improve knee stability and help reduce the re-injury rate compared to isolated anatomical reconstruction with quintuple or sextuple hamstrings that prioritize graft diameter following a well-defined criterion of indication for patients at increased risk of re-injury In this way the investigators intend to compare two methods through a randomized clinical trial intra- and extra-articular reconstruction of the ACL with ALL with hamstring autograft versus isolated anatomical reconstruction of the ACL with quintuple or sextuple hamstring autograft
2 Hypothesis Anatomical ACL reconstruction associated with extra-articular ALL reconstruction with hamstring autograft will present better functional results better stability lower clinical failure rate and lower graft rupture rate when compared to isolated intra-articular anatomical ACL reconstruction with quintuple or sextuple hamstring autograft
3 Objectives To compare the functional results stability clinical failure rate and graft rupture rate of individuals undergoing anatomical ACL reconstruction associated with extra-articular ALL reconstruction with hamstring autograft compared to isolated intra-articular anatomical ACL reconstruction with quintuple or sextuple hamstring autograft
4 Group Formation and Intervention Description
After randomization two groups will be formed
Group A Anatomic ACL Reconstruction combined with Extra-Articular Reconstruction with Anterolateral Ligament The single gracilis strand ALL graft will be passed deep to the iliotibial tract and superficial to the lateral collateral ligament entering the tibial tunnel from proximal to distal with its Ethibond terminal portion tied to the tibial terminal portion of the ACL Ethibond with the knee in extension and neutral rotation - without added fixation devices Wound closure in a layered fashion concludes the procedure
Group B Isolated Intra-Articular Anatomic ACL Reconstruction
5 Patient Evaluation Patients included in the study will be evaluated preoperatively and postoperatively at 3 6 9 12 and 24 months
6 Return to Sport Criteria All patients will be advised to return to sport only after meeting the following criteria full range of motion absence of moderate or severe pain absence of clinical failure criteria a minimum of 9 months post-operative period and completion of FIFA 11 training for prevention for at least 3 months
7 Strategies to Improve Adherence and Monitoring Utilization of the Maia Health Tech platform São Paulo SP Brazil a mobile data collection system with cloud storage and LGPD protection with data anonymization also using WhatsApp for messaging Pre-scheduled messages according to the evaluation timeline will assist in patient adherence and monitoring
8 Circumstances Allowing the Termination of Blinding with Group Revelation Since blinding will occur only for the statistician and partially for data recorders it will exceptionally be necessary to terminate the blinding
9 Data Collection Part of the data will be collected in person by people who will have access to knowledge of which group each patient is in Data will be recorded on the RedCap platform Vanderbilt Tennessee
Part of the data will be collected remotely with blinding using the Maia Health Tech Platform São Paulo SP Brazil a mobile data collection system with cloud storage and HIPAA-compliant protection with data anonymization also using WhatsApp for messaging which will send the following questionnaires to patients IKDC Lysholm KOOS Tegner and VAS One of the investigators will send the patients phone numbers to the platform so that it can send the data to be collected via WhatsApp through the patients number This data will be sent by the Maia Health Tech platform to the RedCap platform autonomously and pre-programmed without anyone involved in the study intermediating
To reduce patient loss during follow-up the current phone number of the patient and the phone numbers of two additional close contacts will be collected in case the patient changes their number The patient will also be instructed to inform the investigator responsible for registering the phone numbers of patients as well as the Maia Health Tech platform of any number changes
The collected data will be submitted to the RedCap platform Only the investigators Marcos Vinicius Credidio Enzo Salviato Mameri and Thiago Bueno Sanchez will have access to this platform
On the RedCap platform the name ID and date of birth of each patient will be included to avoid duplication of records
10 Statistics A priori Power Analysis - Sample Calculation For the sample size calculation the GPower 3197 program httpwwwgpowerhhude was used
To compare if there is a difference in the frequencies of variables related to ACL graft rupture rate and clinical failure rate dichotomous categorical variables between the two groups of interest the Chi-Square test was used For this contingency table the statistical power calculation considered the following criteria significance level α of 5 effect size of 25 and degree of freedom df equal to 1 In a contingency table the df is calculated as follows number of rows - 1 x number of columns - 1 Considering that the study has two groups and that the variables related to the ACL graft rupture rate and clinical failure rate are dichotomous categorical variables the calculated degree of freedom was 1 Thus the sample size calculated for these analyses was 126 individuals Anticipating a 15 loss of patients during follow-up 145 patients will be needed to evaluate the graft rupture rate and clinical failure rate as primary outcomes
To compare if there is a functional difference through the scores obtained from the IKDC Lysholm and KOOS questionnaires numerical variables between the two study groups using the t-Student test parametric or Mann-Whitney test non-parametric using a significance level α of 5 type β error probability of 20 an observed power of 80 1-β and an effect size of 25 the total calculated sample size was 506 patients Anticipating a 15 loss of patients during follow-up 581 patients will be needed to evaluate functional differences initially considered secondary outcomes
11 Statistical Analysis The analysis of quantitative variables will be performed with the calculation of mean standard deviation and 95 confidence interval for each estimated point Secondary variables categories will be analyzed through absolute and relative frequency with a 95 confidence interval calculation Data will be presented in bar graphs and tables for sample characteristics
12 Interim Analysis and Guidelines for Study Termination A partial analysis will be performed halfway through recruitment with a minimum follow-up of 12 months and the study will be interrupted if a 30 difference in the primary outcome is observed The partial analysis will be conducted by a statistician not directly involved in the study and the decision to terminate the study based on the above criteria will be made by the lead researcher
13 General Local Risks and Adverse Effects The main risks regardless of the surgical technique used are as follows anesthetic risk eg inadvertent punctures bleeding in venous or spinal anesthesia access post-spinal anesthesia headache urinary retention surgical site infection swelling and bruising in the knee joint deep vein thrombosis pulmonary embolism neurovascular injuries unsatisfactory results and even death a very rare occurrence but possible in any surgical or anesthetic procedure The postoperative period presents situations of discomfort inherent to the recovery and rehabilitation of the research participant
Adverse effects will be considered any undesirable medical events that the study participant experiences Range of motion will be evaluated with a goniometer to analyze its loss and any other signs of clinical problems such as persistent effusion surgical wound complications and thrombosis will be documented
Serious adverse effects will be considered unexpected surgical or medication effects resulting in death life-threatening conditions requiring hospitalization resulting in permanent disability or necessitating surgical intervention for resolution
14 Benefits for the Patient The benefits to the participant regardless of the surgical technique used which are well-established in the literature and routinely performed by the interventionists include the potential for improved function and reduced pain in the affected limb Additionally patients will undergo physical therapy rehabilitation and receive the necessary analgesic support for comfort and well-being There will be no financial benefit for the patient
15 Study Justification The study aims to elucidate the best method for preparing hamstring autograft grafts for ACL reconstruction using the same amount of implants in both studied techniques As these tendons are the most commonly used grafts for ACL reconstruction worldwide the studys results are expected to have a significant impact on the scientific community aiding in the better treatment choice for patients
16 Funding The study will be self-funded
However instead of using configurations that prioritize increasing the final diameter of hamstring autografts ACL reconstruction associated with extra-articular reconstruction of the anterolateral ligament ALL may be performed using a portion of the gracilis prioritizing the reconstruction of the ALL rather than increasing the intra-articular graft diameter The association of the ALL serves two main functions to decrease rotational instability which can reach up to 40 in high-risk patients and to mechanically protect the graft
In a comparative analysis pairing patients with similar characteristics ACL ALL reconstruction showed significantly lower rerupture rate compared to isolated ACL reconstruction 35 versus 174 In another comparative analysis also pairing patients for similarity isolated ACL reconstruction with bone-patellar tendon-bone BTB autograft showed a 3x higher risk of rerupture compared to ACL ALL reconstruction with hamstring autografts
Thus the investigators hypothesize that extra-articular reinforcement with ALL reconstruction associated with anatomical ACL reconstruction with hamstring autograft may improve knee stability and help reduce the re-injury rate compared to isolated anatomical reconstruction with quintuple or sextuple hamstrings that prioritize graft diameter following a well-defined criterion of indication for patients at increased risk of re-injury In this way the investigators intend to compare two methods through a randomized clinical trial intra- and extra-articular reconstruction of the ACL with ALL with hamstring autograft versus isolated anatomical reconstruction of the ACL with quintuple or sextuple hamstring autograft
2 Hypothesis Anatomical ACL reconstruction associated with extra-articular ALL reconstruction with hamstring autograft will present better functional results better stability lower clinical failure rate and lower graft rupture rate when compared to isolated intra-articular anatomical ACL reconstruction with quintuple or sextuple hamstring autograft
3 Objectives To compare the functional results stability clinical failure rate and graft rupture rate of individuals undergoing anatomical ACL reconstruction associated with extra-articular ALL reconstruction with hamstring autograft compared to isolated intra-articular anatomical ACL reconstruction with quintuple or sextuple hamstring autograft
4 Group Formation and Intervention Description
After randomization two groups will be formed
Group A Anatomic ACL Reconstruction combined with Extra-Articular Reconstruction with Anterolateral Ligament The single gracilis strand ALL graft will be passed deep to the iliotibial tract and superficial to the lateral collateral ligament entering the tibial tunnel from proximal to distal with its Ethibond terminal portion tied to the tibial terminal portion of the ACL Ethibond with the knee in extension and neutral rotation - without added fixation devices Wound closure in a layered fashion concludes the procedure
Group B Isolated Intra-Articular Anatomic ACL Reconstruction
5 Patient Evaluation Patients included in the study will be evaluated preoperatively and postoperatively at 3 6 9 12 and 24 months
6 Return to Sport Criteria All patients will be advised to return to sport only after meeting the following criteria full range of motion absence of moderate or severe pain absence of clinical failure criteria a minimum of 9 months post-operative period and completion of FIFA 11 training for prevention for at least 3 months
7 Strategies to Improve Adherence and Monitoring Utilization of the Maia Health Tech platform São Paulo SP Brazil a mobile data collection system with cloud storage and LGPD protection with data anonymization also using WhatsApp for messaging Pre-scheduled messages according to the evaluation timeline will assist in patient adherence and monitoring
8 Circumstances Allowing the Termination of Blinding with Group Revelation Since blinding will occur only for the statistician and partially for data recorders it will exceptionally be necessary to terminate the blinding
9 Data Collection Part of the data will be collected in person by people who will have access to knowledge of which group each patient is in Data will be recorded on the RedCap platform Vanderbilt Tennessee
Part of the data will be collected remotely with blinding using the Maia Health Tech Platform São Paulo SP Brazil a mobile data collection system with cloud storage and HIPAA-compliant protection with data anonymization also using WhatsApp for messaging which will send the following questionnaires to patients IKDC Lysholm KOOS Tegner and VAS One of the investigators will send the patients phone numbers to the platform so that it can send the data to be collected via WhatsApp through the patients number This data will be sent by the Maia Health Tech platform to the RedCap platform autonomously and pre-programmed without anyone involved in the study intermediating
To reduce patient loss during follow-up the current phone number of the patient and the phone numbers of two additional close contacts will be collected in case the patient changes their number The patient will also be instructed to inform the investigator responsible for registering the phone numbers of patients as well as the Maia Health Tech platform of any number changes
The collected data will be submitted to the RedCap platform Only the investigators Marcos Vinicius Credidio Enzo Salviato Mameri and Thiago Bueno Sanchez will have access to this platform
On the RedCap platform the name ID and date of birth of each patient will be included to avoid duplication of records
10 Statistics A priori Power Analysis - Sample Calculation For the sample size calculation the GPower 3197 program httpwwwgpowerhhude was used
To compare if there is a difference in the frequencies of variables related to ACL graft rupture rate and clinical failure rate dichotomous categorical variables between the two groups of interest the Chi-Square test was used For this contingency table the statistical power calculation considered the following criteria significance level α of 5 effect size of 25 and degree of freedom df equal to 1 In a contingency table the df is calculated as follows number of rows - 1 x number of columns - 1 Considering that the study has two groups and that the variables related to the ACL graft rupture rate and clinical failure rate are dichotomous categorical variables the calculated degree of freedom was 1 Thus the sample size calculated for these analyses was 126 individuals Anticipating a 15 loss of patients during follow-up 145 patients will be needed to evaluate the graft rupture rate and clinical failure rate as primary outcomes
To compare if there is a functional difference through the scores obtained from the IKDC Lysholm and KOOS questionnaires numerical variables between the two study groups using the t-Student test parametric or Mann-Whitney test non-parametric using a significance level α of 5 type β error probability of 20 an observed power of 80 1-β and an effect size of 25 the total calculated sample size was 506 patients Anticipating a 15 loss of patients during follow-up 581 patients will be needed to evaluate functional differences initially considered secondary outcomes
11 Statistical Analysis The analysis of quantitative variables will be performed with the calculation of mean standard deviation and 95 confidence interval for each estimated point Secondary variables categories will be analyzed through absolute and relative frequency with a 95 confidence interval calculation Data will be presented in bar graphs and tables for sample characteristics
12 Interim Analysis and Guidelines for Study Termination A partial analysis will be performed halfway through recruitment with a minimum follow-up of 12 months and the study will be interrupted if a 30 difference in the primary outcome is observed The partial analysis will be conducted by a statistician not directly involved in the study and the decision to terminate the study based on the above criteria will be made by the lead researcher
13 General Local Risks and Adverse Effects The main risks regardless of the surgical technique used are as follows anesthetic risk eg inadvertent punctures bleeding in venous or spinal anesthesia access post-spinal anesthesia headache urinary retention surgical site infection swelling and bruising in the knee joint deep vein thrombosis pulmonary embolism neurovascular injuries unsatisfactory results and even death a very rare occurrence but possible in any surgical or anesthetic procedure The postoperative period presents situations of discomfort inherent to the recovery and rehabilitation of the research participant
Adverse effects will be considered any undesirable medical events that the study participant experiences Range of motion will be evaluated with a goniometer to analyze its loss and any other signs of clinical problems such as persistent effusion surgical wound complications and thrombosis will be documented
Serious adverse effects will be considered unexpected surgical or medication effects resulting in death life-threatening conditions requiring hospitalization resulting in permanent disability or necessitating surgical intervention for resolution
14 Benefits for the Patient The benefits to the participant regardless of the surgical technique used which are well-established in the literature and routinely performed by the interventionists include the potential for improved function and reduced pain in the affected limb Additionally patients will undergo physical therapy rehabilitation and receive the necessary analgesic support for comfort and well-being There will be no financial benefit for the patient
15 Study Justification The study aims to elucidate the best method for preparing hamstring autograft grafts for ACL reconstruction using the same amount of implants in both studied techniques As these tendons are the most commonly used grafts for ACL reconstruction worldwide the studys results are expected to have a significant impact on the scientific community aiding in the better treatment choice for patients
16 Funding The study will be self-funded
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