ACL Reconstruction With Bone Tendon Bone (BTB) Autograft With Versus Without Internal Brace - Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in PROMIS PI CAT at 2 years
研究概览
简要总结
There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.
详细描述
Despite the wide variety of surgical approaches and grafts that can be used in an ACL reconstruction, graft failure and recurrent knee instability are nevertheless ubiquitous issues that have facilitated interest in ways to strengthen the graft at the time of surgery. While both animal and biomechanical models have strongly suggested improved graft strength and patient outcomes by utilizing suture tape augmentation in ACL reconstructions, there is scant clinical literature available to assess these extrapolations. A retrospective cohort study of 60 patients undergoing ACL reconstruction with a hamstring autograft or allograft (30 suture tape vs 30 no suture tape; mean age: 30), found shorter time to return to activity (9.2 months suture tape group vs 12.9 months no suture tape group; p=0.002), lower Western Ontario and McMaster University Osteoarthritis Indices (WOMAC) (2.2 suture tape group vs 6.2 no suture tape group; p=0.024), higher international knee documentation committee (IKDC) scores (87.6 suture tape group vs 73.2 no suture tape group; p=0.006), lower average pain on the national pain rating scale (NPRS) (0.6 suture tape group vs 1.66 no suture tape group; p=0.021) and no significant difference in range of motion in degrees (129 suture tape group vs 127 no suture tape group; p=0.46), knee injury and osteoarthritis outcome score (KOOS) (92.2 suture tape group vs 87.1 no suture tape group; p=0.68), or complications (13% suture tape vs 10% no suture tape; p>0.05) at 2 years follow up. A retrospective cohort study of 108 patients undergoing ACL reconstruction with a hamstring autograft with and without suture tape reinforcement (36 suture tape vs 72 no suture tape; mean age: 25), found a significantly higher Tegner activity score (7.1 suture tape group vs 6.4 no suture tape group; p=0.026) but otherwise no significant difference in time to preinjury activity level (11.9 mos suture tape group vs 11.6 no suture tape group; p=0.59), range of motion (degrees) (136 suture tape group vs 137 no suture tape group; p=0.44) , Lysholm knee score (95.6 suture tape group vs 94 no suture tape group; p=0.165), IKDC score (94.4 suture tape group vs 93.8 no suture tape group; p=0.44), or complications (6% suture tape group vs 5% no suture tape group; p>0.05) at 2 years follow up. A prospective cohort study of 50 ACL reconstructions with hamstring autograft with and without suture tape reinforcement (25 suture tape group vs 25 no suture tape group; mean age: 30), found a significant improvement in greater than 2 grades of Lachman testing from preoperative assessment compared to 6 months follow-up (68% suture tape group vs 32% no suture tape group; p=0.039) but no difference in Lysholm knee score at 6 months (87.0 suture tape group vs 87.0 no suture tape group; p=0.756). Moreover, none of the already-limited clinical data investigates the use of internal braces with bone-tendon-bone grafts, which are a popular choice for young adults and athletes. Furthermore, there are no current level 1 data on this subject. Therefore, this study aims to compare the time to return to pre- injury activity level, incidence of recurrent knee instability, and patient reported outcomes of patients treated with ACL reconstruction using bone-tendon-bone autograft with and without (control group) internal brace stabilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients 12 and older
- •patients seen by the Columbia University Sports Medicine Service
- •patients diagnosed with a first time ACL injury by clinical exam and MRI
排除标准
- •previous knee surgery
- •concurrent knee fracture or ligamentous injury on ipsilateral knee
- •neuromuscular disorder involving lower limb
- •inability/ unwillingness to adhere to protocol
- •anesthesia contraindications
- •lost to follow up
结局指标
主要结局
Change in PROMIS PI CAT at 2 years
时间窗: Baseline and 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
Time to Return to Full Activity or Sports
时间窗: Measured once per participant, depending on the time required to return to full activity (up to 10 years)
Time from treatment initiation to full return to pre-injury activity levels in each group, expressed in weeks
Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks
时间窗: Baseline and 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 6 weeks
时间窗: Baseline and 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 10 years
时间窗: Baseline and 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 3 months
时间窗: Baseline and 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 2 years
时间窗: Baseline and 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 5 years
时间窗: Baseline and 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 5 years
时间窗: Baseline and 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 1 year
时间窗: Baseline and 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS Pain Interference (PI) CAT at 2 weeks
时间窗: Baseline and 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 6 weeks
时间窗: Baseline and 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 6 months
时间窗: Baseline and 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
Percentage of Participants with Recurrent Knee Instability
时间窗: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Percentage of participants that experience recurrent instability after treatment starts at each time point
Change in PROMIS PF CAT at 6 months
时间窗: Baseline and 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 3 months
时间窗: Baseline and 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 1 year
时间窗: Baseline and 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 6 weeks
时间窗: Baseline and 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 3 months
时间窗: Baseline and 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 10 years
时间窗: Baseline and 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 2 weeks
时间窗: Baseline and 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 6 months
时间窗: Baseline and 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 1 year
时间窗: Baseline and 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 2 years
时间窗: Baseline and 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 5 years
时间窗: Baseline and 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 10 years
时间窗: Baseline and 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
次要结局
- Change in International Knee Documentation Committee (IKDC) Score at 2 weeks(Baseline and 2 weeks)
- Change in numeric pain rating scale (NPRS) Score at 2 weeks(Baseline and 2 weeks)
- Change in numeric pain rating scale (NPRS) Score at 2 years(Baseline and 2 years)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks(Baseline and 6 weeks)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 5 years(Baseline and 5 years)
- Change in Tegner activity scale (TAS) Score at 2 years(Baseline and 2 years)
- Change in Tegner activity scale (TAS) Score at 10 years(Baseline and 10 years)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks(Baseline and 2 weeks)
- Change in International Knee Documentation Committee (IKDC) Score at 3 months(Baseline and 3 months)
- Change in International Knee Documentation Committee (IKDC) Score at 6 months(Baseline and 6 months)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 years(Baseline and 2 years)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 years(Baseline and 10 years)
- Change in Tegner activity scale (TAS) Score at 2 weeks(Baseline and 2 weeks)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks(Baseline and 6 weeks)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months(Baseline and 6 months)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 5 years(Baseline and 5 years)
- Change in International Knee Documentation Committee (IKDC) Score at 5 years(Baseline and 5 years)
- Change in numeric pain rating scale (NPRS) Score at 5 years(Baseline and 5 years)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 weeks(Baseline and 2 weeks)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 year(Baseline and 1 year)
- Change in Tegner activity scale (TAS) Score at 3 months(Baseline and 3 months)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 years(Baseline and 2 years)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 10 years(Baseline and 10 years)
- Change in International Knee Documentation Committee (IKDC) Score at 6 weeks(Baseline and 6 weeks)
- Change in International Knee Documentation Committee (IKDC) Score at 1 year(Baseline and 1 year)
- Change in International Knee Documentation Committee (IKDC) Score at 10 years(Baseline and 10 years)
- Change in numeric pain rating scale (NPRS) Score at 3 months(Baseline and 3 months)
- Change in numeric pain rating scale (NPRS) Score at 6 months(Baseline and 6 months)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months(Baseline and 6 months)
- Change in Tegner activity scale (TAS) Score at 6 weeks(Baseline and 6 weeks)
- Change in Tegner activity scale (TAS) Score at 6 months(Baseline and 6 months)
- Change in Tegner activity scale (TAS) Score at 5 years(Baseline and 5 years)
- Change in numeric pain rating scale (NPRS) Score at 1 year(Baseline and 1 year)
- Change in Lysholm Score at 6 months(Baseline and 6 months)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months(Baseline and 3 months)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 year(Baseline and 1 year)
- Change in International Knee Documentation Committee (IKDC) Score at 2 years(Baseline and 2 years)
- Change in numeric pain rating scale (NPRS) Score at 6 weeks(Baseline and 6 weeks)
- Change in numeric pain rating scale (NPRS) Score at 10 years(Baseline and 10 years)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months(Baseline and 3 months)
- Change in Tegner activity scale (TAS) Score at 1 year(Baseline and 1 year)
- Change in Lysholm Score at 2 weeks(Baseline and 2 weeks)
- Change in Lysholm Score at 3 months(Baseline and 3 months)
- Change in Lysholm Score at 6 weeks(Baseline and 6 weeks)
- Change in Lysholm Score at 1 year(Baseline and 1 year)
- Change in Lysholm Score at 2 years(Baseline and 2 years)
- Change in Lysholm Score at 5 years(Baseline and 5 years)
- Change in Lysholm Score at 10 years(Baseline and 10 years)