Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198042
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2005-09-13
Brief Title:
Bone Tunnel Widening Following ACL Reconstruction
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Bone Tunnel Widening Following ACL Reconstruction
Status:
COMPLETED
Status Verified Date:
2017-05
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:
None
Brief Summary:
Hypothesis 1 There is less tunnel-widening with bone-patella tendon-bone graft compared with the hamstring graft when the same fixation method is used Tunnel widening is greater with achilles tendon allografts versus autograft bone-patella tendon-bone and hamstring autografts
Hypothesis 2 Tunnel widening occurs in the early post-operative period 8 weeks when the tendon remodels within the bone tunnels
Hypothesis 3 Low pre-operative bone mineral density is associated with tunnel widening
Hypothesis 2 Tunnel widening occurs in the early post-operative period 8 weeks when the tendon remodels within the bone tunnels
Hypothesis 3 Low pre-operative bone mineral density is associated with tunnel widening
Detailed Description:
This will be a prospective study for patients undergoing ACL reconstruction using bone-patella tendon-bone graft hamstring graft or achilles allograft Each group will have ACL reconstruction with fixation using bioabsorbable interference screws on the femoral and tibial side Patients will be evaluated on the day of surgery 6 12 24 52 and 104 weeks post-operatively Evaluations will include pre-operative regional and standard bone mineral density measurements post-operative MRI evaluation of tunnel dimensions and bone-tendon interface radiographic evaluation of tunnel dimensions and routine clinical follow-up
Interventions or Observations - outline specific procedures treatments andor interventions as well as sources of research material to be utilized which will involve human subjects or human materials that will be part of this research project
This study will require a pre-operative bone mineral density measurement in the Nuclear Medicine Division of the Department of Radiology at HSS Standard measurements of the femoral neck spine as well as regional studies of the distal femur and proximal tibia of the injured knee will be performed
On the day of surgery the patient will undergo ACL reconstruction using bioabsorbable interference screw fixation of the hamstring bone-patella tendon-bone graft or achilles allograft This is a standard procedure The choice of graft type hamstring bone-patella tendon-bone graft or achilles allograft will be discussed with the patients and the patient will decide graft type pre-operatively In this study we will standardize the fixation method by using bioabsorbable interference screws Post-operatively the patient will undergo a limited MRI scan to evaluate the tunnel dimensions as well as graft placement prior to discharge from the hospital
During the patients 6 weeks 12 weeks and 24 weeks clinical follow-up they will be evaluated by their orthopaedic surgeon for clinical progress Standard radiographs will be obtained of the patients knee at the 6 weeks and 24 weeks follow-up visit These are standard radiographic evaluations and are of no additional charge to the patients We will utilize these images for radiographic measurements of tunnel expansion During these visits the patients will also undergo limited MRI scan of the femoral tunnel and tibia tunnel With the serial MRI images we will be able to make accurate measurements of the femoral and tibial tunnels In addition we will be able to evaluate the bone-tendon interface as well as the maturation of the intra-articular portion of the ACL graft At 24 52 and 104 weeks the patients will also be given standard IKDC and Lysholm clinical knee outcome questionnaires and will have objective stability measurements of both the operative and non-operative knees using a KT-1000 instrument
Overall Study Protocol
Pre-operative work-up
1 Bone mineral density measurement by DEXA
Day of Surgery
1 ACL reconstruction using bioabsorbable interference screws
2 Limited CT scans to quantitate tunnel dimensions
6 weeks post-operatively
1 Regular clinical follow-up
2 Regular plain radiographs to quantitate tunnel dimensions
3 Limited MRI scans to quantitate tunnel dimensions
12 weeks post-operatively
1 Regular clinical follow-up
2 Limited MRI scans to quantitate tunnel dimensions
24 weeks post-operatively
1 Regular clinical follow-up and KT-1000 measurements
2 Regular plain radiographs to quantitate tunnel dimensions
3 MRI study to evaluate tendon-bone interface graft maturation tunnel dimensions and trabecular remodeling
4 Patients will answer IKDC and Lysholm knee questionnaires
52 weeks post-operatively
1 Regular clinical follow-up and KT-1000 measurements
2 Patients will answer IKDC and Lysholm knee questionnaires
3 Limited MRI
104 weeks post-operatively
1 Regular clinical follow-up and KT-1000 measurements
2 Patients will answer IKDC and Lysholm knee questionnaires
3 Limited MRI
Number of Subjects power justification for numbers
A power analysis was performed to determine the number of subjects needed to determine significance between the hamstring and bone-patella tendon-bone group Data from previous studies demonstrate tunnel widening up to 77 28 following ACL reconstruction using hamstring tendons We estimate that a 30 decrease in this amount of tunnel widening would be clinically significant This extrapolates to a 54 increase in tunnel dimensions Using these estimations a power of 080 with α 05 is achieved using 20 subjects per group BPTB versus hamstring
Interventions or Observations - outline specific procedures treatments andor interventions as well as sources of research material to be utilized which will involve human subjects or human materials that will be part of this research project
This study will require a pre-operative bone mineral density measurement in the Nuclear Medicine Division of the Department of Radiology at HSS Standard measurements of the femoral neck spine as well as regional studies of the distal femur and proximal tibia of the injured knee will be performed
On the day of surgery the patient will undergo ACL reconstruction using bioabsorbable interference screw fixation of the hamstring bone-patella tendon-bone graft or achilles allograft This is a standard procedure The choice of graft type hamstring bone-patella tendon-bone graft or achilles allograft will be discussed with the patients and the patient will decide graft type pre-operatively In this study we will standardize the fixation method by using bioabsorbable interference screws Post-operatively the patient will undergo a limited MRI scan to evaluate the tunnel dimensions as well as graft placement prior to discharge from the hospital
During the patients 6 weeks 12 weeks and 24 weeks clinical follow-up they will be evaluated by their orthopaedic surgeon for clinical progress Standard radiographs will be obtained of the patients knee at the 6 weeks and 24 weeks follow-up visit These are standard radiographic evaluations and are of no additional charge to the patients We will utilize these images for radiographic measurements of tunnel expansion During these visits the patients will also undergo limited MRI scan of the femoral tunnel and tibia tunnel With the serial MRI images we will be able to make accurate measurements of the femoral and tibial tunnels In addition we will be able to evaluate the bone-tendon interface as well as the maturation of the intra-articular portion of the ACL graft At 24 52 and 104 weeks the patients will also be given standard IKDC and Lysholm clinical knee outcome questionnaires and will have objective stability measurements of both the operative and non-operative knees using a KT-1000 instrument
Overall Study Protocol
Pre-operative work-up
1 Bone mineral density measurement by DEXA
Day of Surgery
1 ACL reconstruction using bioabsorbable interference screws
2 Limited CT scans to quantitate tunnel dimensions
6 weeks post-operatively
1 Regular clinical follow-up
2 Regular plain radiographs to quantitate tunnel dimensions
3 Limited MRI scans to quantitate tunnel dimensions
12 weeks post-operatively
1 Regular clinical follow-up
2 Limited MRI scans to quantitate tunnel dimensions
24 weeks post-operatively
1 Regular clinical follow-up and KT-1000 measurements
2 Regular plain radiographs to quantitate tunnel dimensions
3 MRI study to evaluate tendon-bone interface graft maturation tunnel dimensions and trabecular remodeling
4 Patients will answer IKDC and Lysholm knee questionnaires
52 weeks post-operatively
1 Regular clinical follow-up and KT-1000 measurements
2 Patients will answer IKDC and Lysholm knee questionnaires
3 Limited MRI
104 weeks post-operatively
1 Regular clinical follow-up and KT-1000 measurements
2 Patients will answer IKDC and Lysholm knee questionnaires
3 Limited MRI
Number of Subjects power justification for numbers
A power analysis was performed to determine the number of subjects needed to determine significance between the hamstring and bone-patella tendon-bone group Data from previous studies demonstrate tunnel widening up to 77 28 following ACL reconstruction using hamstring tendons We estimate that a 30 decrease in this amount of tunnel widening would be clinically significant This extrapolates to a 54 increase in tunnel dimensions Using these estimations a power of 080 with α 05 is achieved using 20 subjects per group BPTB versus hamstring
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