Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture, Chronic Instability of Knee, Deficiency of Anterior Cruciate Ligament
Conditions
Keywords
Anterior Cruciate Ligament (ACL) Reconstruction, Patellar Tendon, Hamstring Tendon, Double-Bundle, Autograft
Brief summary
The purpose of this randomized clinical trial is to determine the difference in quality of life outcome at two years, in patients undergoing an Anterior Cruciate Ligament (ACL) reconstruction procedure with either a patellar tendon, quadruple hamstring tendon or a double-bundle hamstring tendon autograft.
Detailed description
Following an ACL injury, the knee is predisposed to chronic instability, further damage to the meniscal and chondral structures in the knee, osteoarthritis and an impaired quality of life. The successful treatment of an ACL deficient knee aims to preserve the intact meniscus and chondral structures, and to provide a functionally stable knee so that patients can return to pre-injury activities and restore their quality of life. The current standard of care for ACL deficient knees is with a surgical ACL reconstruction procedure. A Cochrane Review was done and demonstrated that the existing literature is controversial. To date, no existing trial has used validated patient-based outcome assessment, accounted for the critical differences between acute and chronic ACL deficiency or used modern techniques to ensure randomization concealment and a sufficient sample size to avoid type II error. The existing information does not define graft failure or re-ruptures, involve long-term follow-up to address osteoarthritis development, nor compare outcomes between single- and double-bundle reconstructive techniques. The current standard includes either a patellar tendon or quadruple semitendinosus/gracilis tendon autograft reconstruction. The newest option is a double-bundle semitendinosus/gracilis graft. This option attempts to restore the complex ACL anatomy by using two separate tendon components to reconstruct the ACL. This study will measure disease-specific quality of life at short- and long-term post-operative intervals (1, 2, 5 and 10 years). Additional secondary outcomes, including the incidence of traumatic re-ruptures and graft failures, will also be compared between treatment groups.
Interventions
PROCEDUREPatellar Tendon
Patellar Tendon autograft
PROCEDUREHamstring Tendon
Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft
PROCEDUREDouble-Bundle
Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Sponsors
Workers' Compensation Board, Alberta
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
A confirmed diagnosis of anterior cruciate ligament deficiency based on all of the following: * History of a traumatic injury episode * Physical examination findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test) * A positive pivot shift test * X-rays showing skeletal maturity (ie: tibial tubercle fused) and no fractures. (NB: Magnetic resonance imaging is not required) * Age 14-50 years old
Exclusion criteria
* Patients with combined ligament deficiencies (Posterior Cruciate, Medial and/or Lateral Collateral deficiency.) (NB: Grade 1 side to side differences (ie. \< 5mm) on valgus, varus or posterior stress testing will not be considered exclusions) * Intra-operative identification of International Cartilage Repair Society (ICRS) Grade 4 chondral lesion of \> 1 cm ² \[61\] * Previous ligament surgery on the affected or contralateral knees * Cases involving litigation or Worker's Compensation * Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfans) * X-ray showing that tibial physis is not fused
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively | The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-year Follow-up, 5-Year Follow-up, 10-Year Follow-up | * COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (\>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy. * PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a complete traumatic rerupture. Confirmed by MR or diagnostic arthroscopy. * TRAUMATIC RE-INJURY - combined total of complete traumatic re-ruptures and partial traumatic tears. * ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer. |
| Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline, 1, 2, 5 years post-operatively | IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation). |
| Mean International Knee Documentation Committee (IKDC) Subjective Score | Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively | Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome. |
| Number of Participants With Each Pivot Shift Grade | Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively | The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee. Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament. |
| Proportion of Patients With Moderate or Severe Kneeling Pain | Baseline, 2 and 5 years post-operatively | Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions. |
| Mean Tegner Activity Level | Baseline, 6 months, 1 and 2 years post-operatively | Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)) |
| Return to Pre-injury Tegner Activity Level | 1, 2 and 5 years post-operatively | Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)). |
| Cincinnati Occupational Rating Scale | Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively | The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities. |
| Skin-to-Skin Operative Times | During surgery | Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure |
| Radiographic (X-ray) Changes | Baseline, 2 and 5 years post-operatively | The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays. |
| Knee Laxity as Measured by the KT Arthrometer | Baseline, 1 and 2 years post-operatively | Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | 2 years post-operatively | All complications/adverse events that occurred within the first two-years post-operatively. See Adverse Events section for results of this outcome. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patellar Tendon (PT) ACL reconstruction using a patellar tendon autograft
Patellar Tendon: Patellar Tendon autograft | 110 |
| Hamstring (HT) ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft
Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft | 110 |
| Double-Bundle (DB) ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft
Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft | 110 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 2-Year Follow-up | Lost to Follow-up | 1 | 2 | 2 |
| 2-Year Follow-up | Withdrawal by Subject | 3 | 0 | 0 |
| 5-Year Follow-up | Lost to Follow-up | 2 | 3 | 1 |
| 5-Year Follow-up | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Patellar Tendon (PT) | Hamstring (HT) | Double-Bundle (DB) | Total |
|---|---|---|---|---|
| Age, Continuous | 28.7 years STANDARD_DEVIATION 9.7 | 28.5 years STANDARD_DEVIATION 9.9 | 28.3 years STANDARD_DEVIATION 9.8 | 28.5 years STANDARD_DEVIATION 9.8 |
| Chronicity: Acute, Chronic Acute | 16 Participants | 16 Participants | 17 Participants | 49 Participants |
| Chronicity: Acute, Chronic Chronic | 94 Participants | 94 Participants | 93 Participants | 281 Participants |
| Injured side: Left, Right Left | 54 Participants | 63 Participants | 54 Participants | 171 Participants |
| Injured side: Left, Right Right | 56 Participants | 47 Participants | 56 Participants | 159 Participants |
| Sex: Female, Male Female | 47 Participants | 51 Participants | 49 Participants | 147 Participants |
| Sex: Female, Male Male | 63 Participants | 59 Participants | 61 Participants | 183 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 110 | 0 / 110 |
| other Total, other adverse events | 20 / 110 | 22 / 110 | 38 / 110 |
| serious Total, serious adverse events | 0 / 110 | 1 / 110 | 2 / 110 |
Outcome results
Primary
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome
The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life.
Time frame: Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively
Population: There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patellar Tendon (PT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | Baseline | 27.0 Score (0 to 100) | Standard Deviation 13.1 |
| Patellar Tendon (PT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 3 Months | 47.7 Score (0 to 100) | Standard Deviation 17.2 |
| Patellar Tendon (PT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 6 Months | 61.7 Score (0 to 100) | Standard Deviation 19.1 |
| Patellar Tendon (PT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 1-Year | 74.5 Score (0 to 100) | Standard Deviation 18.7 |
| Patellar Tendon (PT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 2-Years | 84.6 Score (0 to 100) | Standard Deviation 16.6 |
| Patellar Tendon (PT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 5-Years | 82.5 Score (0 to 100) | Standard Deviation 17.9 |
| Hamstring (HT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 1-Year | 75.4 Score (0 to 100) | Standard Deviation 18.5 |
| Hamstring (HT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | Baseline | 29.8 Score (0 to 100) | Standard Deviation 14.7 |
| Hamstring (HT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 6 Months | 65.2 Score (0 to 100) | Standard Deviation 18.4 |
| Hamstring (HT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 5-Years | 83.9 Score (0 to 100) | Standard Deviation 18.2 |
| Hamstring (HT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 3 Months | 52.6 Score (0 to 100) | Standard Deviation 19.2 |
| Hamstring (HT) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 2-Years | 82.5 Score (0 to 100) | Standard Deviation 17.7 |
| Double-Bundle (DB) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 3 Months | 50.5 Score (0 to 100) | Standard Deviation 16.9 |
| Double-Bundle (DB) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 6 Months | 65.5 Score (0 to 100) | Standard Deviation 17.9 |
| Double-Bundle (DB) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 5-Years | 81.1 Score (0 to 100) | Standard Deviation 19.3 |
| Double-Bundle (DB) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 1-Year | 73.6 Score (0 to 100) | Standard Deviation 19.2 |
| Double-Bundle (DB) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 2-Years | 82.4 Score (0 to 100) | Standard Deviation 17.5 |
| Double-Bundle (DB) | Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | Baseline | 28.7 Score (0 to 100) | Standard Deviation 13.7 |
Comparison: All patients were analyzed on an intention-to-treat basis using a 5% significance level for all analyses. The ACL-QOL scores for each study group were analyzed using adjusted Bonferroni comparisons and repeated-measures analyses, using a mixed-model analysis of variance for treatment group over time of assessment.p-value: <0.05Mixed Models Analysis
Secondary
Cincinnati Occupational Rating Scale
The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities.
Time frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
Population: There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patellar Tendon (PT) | Cincinnati Occupational Rating Scale | Baseline | 36.6 score on a scale (out of 100) | Standard Deviation 19.9 |
| Patellar Tendon (PT) | Cincinnati Occupational Rating Scale | 3 Months | 34.7 score on a scale (out of 100) | Standard Deviation 17.2 |
| Patellar Tendon (PT) | Cincinnati Occupational Rating Scale | 6 Months | 35.7 score on a scale (out of 100) | Standard Deviation 18.3 |
| Patellar Tendon (PT) | Cincinnati Occupational Rating Scale | 1 Year | 36.7 score on a scale (out of 100) | Standard Deviation 17.2 |
| Patellar Tendon (PT) | Cincinnati Occupational Rating Scale | 2 Years | 36.8 score on a scale (out of 100) | Standard Deviation 19.4 |
| Patellar Tendon (PT) | Cincinnati Occupational Rating Scale | 5 Years | 35.9 score on a scale (out of 100) | Standard Deviation 18.4 |
| Hamstring (HT) | Cincinnati Occupational Rating Scale | 5 Years | 36.6 score on a scale (out of 100) | Standard Deviation 23.8 |
| Hamstring (HT) | Cincinnati Occupational Rating Scale | Baseline | 35.4 score on a scale (out of 100) | Standard Deviation 21.3 |
| Hamstring (HT) | Cincinnati Occupational Rating Scale | 1 Year | 38.0 score on a scale (out of 100) | Standard Deviation 22 |
| Hamstring (HT) | Cincinnati Occupational Rating Scale | 2 Years | 34.4 score on a scale (out of 100) | Standard Deviation 22.1 |
| Hamstring (HT) | Cincinnati Occupational Rating Scale | 3 Months | 36.1 score on a scale (out of 100) | Standard Deviation 22.1 |
| Hamstring (HT) | Cincinnati Occupational Rating Scale | 6 Months | 37.4 score on a scale (out of 100) | Standard Deviation 21.6 |
| Double-Bundle (DB) | Cincinnati Occupational Rating Scale | 3 Months | 36.4 score on a scale (out of 100) | Standard Deviation 19.3 |
| Double-Bundle (DB) | Cincinnati Occupational Rating Scale | 6 Months | 37.0 score on a scale (out of 100) | Standard Deviation 20.2 |
| Double-Bundle (DB) | Cincinnati Occupational Rating Scale | 5 Years | 37.8 score on a scale (out of 100) | Standard Deviation 24.2 |
| Double-Bundle (DB) | Cincinnati Occupational Rating Scale | 1 Year | 38.0 score on a scale (out of 100) | Standard Deviation 21.5 |
| Double-Bundle (DB) | Cincinnati Occupational Rating Scale | Baseline | 36.3 score on a scale (out of 100) | Standard Deviation 17.7 |
| Double-Bundle (DB) | Cincinnati Occupational Rating Scale | 2 Years | 38.0 score on a scale (out of 100) | Standard Deviation 22.5 |
Secondary
Knee Laxity as Measured by the KT Arthrometer
Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.
Time frame: Baseline, 1 and 2 years post-operatively
Population: There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patellar Tendon (PT) | Knee Laxity as Measured by the KT Arthrometer | 1-Year | 1.9 Millimetres (side-to-side difference) | Standard Deviation 2.3 |
| Patellar Tendon (PT) | Knee Laxity as Measured by the KT Arthrometer | Baseline | 4.9 Millimetres (side-to-side difference) | Standard Deviation 2.3 |
| Patellar Tendon (PT) | Knee Laxity as Measured by the KT Arthrometer | 2-Years | 1.9 Millimetres (side-to-side difference) | Standard Deviation 2.5 |
| Hamstring (HT) | Knee Laxity as Measured by the KT Arthrometer | 1-Year | 2.8 Millimetres (side-to-side difference) | Standard Deviation 1.8 |
| Hamstring (HT) | Knee Laxity as Measured by the KT Arthrometer | Baseline | 5.0 Millimetres (side-to-side difference) | Standard Deviation 2.1 |
| Hamstring (HT) | Knee Laxity as Measured by the KT Arthrometer | 2-Years | 3.0 Millimetres (side-to-side difference) | Standard Deviation 2.1 |
| Double-Bundle (DB) | Knee Laxity as Measured by the KT Arthrometer | Baseline | 5.1 Millimetres (side-to-side difference) | Standard Deviation 2.3 |
| Double-Bundle (DB) | Knee Laxity as Measured by the KT Arthrometer | 2-Years | 2.7 Millimetres (side-to-side difference) | Standard Deviation 2.4 |
| Double-Bundle (DB) | Knee Laxity as Measured by the KT Arthrometer | 1-Year | 2.8 Millimetres (side-to-side difference) | Standard Deviation 2.2 |
Secondary
Mean International Knee Documentation Committee (IKDC) Subjective Score
Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.
Time frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
Population: There were 110 participants randomized to each study group. At 1-, 2- and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patellar Tendon (PT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | Baseline | 50.1 score on a scale (out of 100) | Standard Deviation 13.9 |
| Patellar Tendon (PT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 3 Months | 60.2 score on a scale (out of 100) | Standard Deviation 12.2 |
| Patellar Tendon (PT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 6 Months | 71.1 score on a scale (out of 100) | Standard Deviation 11.1 |
| Patellar Tendon (PT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 1-Year | 79.7 score on a scale (out of 100) | Standard Deviation 11.7 |
| Patellar Tendon (PT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 2-Years | 84.6 score on a scale (out of 100) | Standard Deviation 13.8 |
| Patellar Tendon (PT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 5-Years | 83.9 score on a scale (out of 100) | Standard Deviation 12.9 |
| Hamstring (HT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 5-Years | 85.2 score on a scale (out of 100) | Standard Deviation 13 |
| Hamstring (HT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | Baseline | 51.0 score on a scale (out of 100) | Standard Deviation 16.2 |
| Hamstring (HT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 1-Year | 81.7 score on a scale (out of 100) | Standard Deviation 12.6 |
| Hamstring (HT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 2-Years | 85.3 score on a scale (out of 100) | Standard Deviation 11.6 |
| Hamstring (HT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 3 Months | 65.7 score on a scale (out of 100) | Standard Deviation 14.2 |
| Hamstring (HT) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 6 Months | 76.1 score on a scale (out of 100) | Standard Deviation 13.1 |
| Double-Bundle (DB) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 3 Months | 63.1 score on a scale (out of 100) | Standard Deviation 12.1 |
| Double-Bundle (DB) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 6 Months | 75.8 score on a scale (out of 100) | Standard Deviation 11.1 |
| Double-Bundle (DB) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 5-Years | 84.3 score on a scale (out of 100) | Standard Deviation 13.4 |
| Double-Bundle (DB) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 1-Year | 80.0 score on a scale (out of 100) | Standard Deviation 11.9 |
| Double-Bundle (DB) | Mean International Knee Documentation Committee (IKDC) Subjective Score | Baseline | 51.5 score on a scale (out of 100) | Standard Deviation 14.6 |
| Double-Bundle (DB) | Mean International Knee Documentation Committee (IKDC) Subjective Score | 2-Years | 84.2 score on a scale (out of 100) | Standard Deviation 11.8 |
Secondary
Mean Tegner Activity Level
Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))
Time frame: Baseline, 6 months, 1 and 2 years post-operatively
Population: There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patellar Tendon (PT) | Mean Tegner Activity Level | Baseline | 7.7 Activity Level | Standard Deviation 1.7 |
| Patellar Tendon (PT) | Mean Tegner Activity Level | 6 Months | 4.7 Activity Level | Standard Deviation 1.6 |
| Patellar Tendon (PT) | Mean Tegner Activity Level | 1 Year | 6.0 Activity Level | Standard Deviation 1.8 |
| Patellar Tendon (PT) | Mean Tegner Activity Level | 2 Years | 6.5 Activity Level | Standard Deviation 1.8 |
| Hamstring (HT) | Mean Tegner Activity Level | 2 Years | 6.4 Activity Level | Standard Deviation 2 |
| Hamstring (HT) | Mean Tegner Activity Level | Baseline | 7.9 Activity Level | Standard Deviation 1.7 |
| Hamstring (HT) | Mean Tegner Activity Level | 1 Year | 6.1 Activity Level | Standard Deviation 1.9 |
| Hamstring (HT) | Mean Tegner Activity Level | 6 Months | 4.8 Activity Level | Standard Deviation 1.6 |
| Double-Bundle (DB) | Mean Tegner Activity Level | 2 Years | 6.4 Activity Level | Standard Deviation 1.9 |
| Double-Bundle (DB) | Mean Tegner Activity Level | 6 Months | 5.0 Activity Level | Standard Deviation 1.7 |
| Double-Bundle (DB) | Mean Tegner Activity Level | 1 Year | 5.9 Activity Level | Standard Deviation 2 |
| Double-Bundle (DB) | Mean Tegner Activity Level | Baseline | 7.9 Activity Level | Standard Deviation 1.6 |
Secondary
Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade
IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation).
Time frame: Baseline, 1, 2, 5 years post-operatively
Population: There were 110 participants randomized to each study group. At 1-, 2-, and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Normal (A) | 9 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Nearly Normal (B) | 1 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Abnormal (C) | 103 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Severely Abnormal (D) | 5 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Normal (A) | 0 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Nearly Normal (B) | 79 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Abnormal (C) | 13 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Severely Abnormal (D) | 0 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Normal (A) | 12 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Nearly Normal (B) | 65 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Abnormal (C) | 23 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Severely Abnormal (D) | 1 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Normal (A) | 24 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Nearly Normal (B) | 61 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Abnormal (C) | 13 Participants |
| Patellar Tendon (PT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Severely Abnormal (D) | 0 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Nearly Normal (B) | 77 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Abnormal (C) | 18 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Severely Abnormal (D) | 0 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Nearly Normal (B) | 63 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Normal (A) | 12 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Nearly Normal (B) | 62 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Severely Abnormal (D) | 0 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Abnormal (C) | 28 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Normal (A) | 0 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Abnormal (C) | 18 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Nearly Normal (B) | 4 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Severely Abnormal (D) | 2 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Abnormal (C) | 101 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Severely Abnormal (D) | 4 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Normal (A) | 9 Participants |
| Hamstring (HT) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Normal (A) | 18 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Abnormal (C) | 30 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Nearly Normal (B) | 71 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Normal (A) | 19 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Abnormal (C) | 100 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Abnormal (C) | 19 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Severely Abnormal (D) | 2 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Normal (A) | 0 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Severely Abnormal (D) | 2 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Severely Abnormal (D) | 2 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 1-Year | Normal (A) | 9 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Normal (A) | 19 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Nearly Normal (B) | 58 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Nearly Normal (B) | 5 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 2-Years | Nearly Normal (B) | 56 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | Baseline | Severely Abnormal (D) | 5 Participants |
| Double-Bundle (DB) | Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 5-Years | Abnormal (C) | 24 Participants |
Secondary
Number of Participants With Each Pivot Shift Grade
The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee. Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.
Time frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
Population: There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 3 Months | Clunk (++) | 1 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | Baseline | Equal | 0 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | Baseline | Glide (+) | 6 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | Baseline | Clunk (++) | 103 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | Baseline | Gross (+++) | 1 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 3 Months | Equal | 73 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 3 Months | Glide (+) | 30 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 3 Months | Gross (+++) | 0 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 6 Months | Equal | 62 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 6 Months | Glide (+) | 38 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 6 Months | Clunk (++) | 3 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 6 Months | Gross (+++) | 0 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 1-Year | Equal | 47 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 1-Year | Glide (+) | 51 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 1-Year | Clunk (++) | 3 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 1-Year | Gross (+++) | 0 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 2-Years | Equal | 36 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 2-Years | Glide (+) | 52 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 2-Years | Clunk (++) | 14 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 2-Years | Gross (+++) | 0 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 5-Years | Equal | 37 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 5-Years | Glide (+) | 50 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 5-Years | Clunk (++) | 12 Participants |
| Patellar Tendon (PT) | Number of Participants With Each Pivot Shift Grade | 5-Years | Gross (+++) | 0 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 5-Years | Glide (+) | 54 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 1-Year | Equal | 46 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 2-Years | Equal | 28 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 6 Months | Clunk (++) | 5 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | Baseline | Glide (+) | 6 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 5-Years | Equal | 29 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 1-Year | Glide (+) | 48 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | Baseline | Clunk (++) | 102 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 5-Years | Clunk (++) | 16 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 2-Years | Glide (+) | 57 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | Baseline | Gross (+++) | 1 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 6 Months | Glide (+) | 45 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 1-Year | Clunk (++) | 12 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 3 Months | Equal | 60 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 6 Months | Gross (+++) | 0 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 5-Years | Gross (+++) | 0 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 3 Months | Glide (+) | 45 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 6 Months | Equal | 53 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | Baseline | Equal | 1 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 3 Months | Clunk (++) | 1 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 1-Year | Gross (+++) | 0 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 2-Years | Clunk (++) | 18 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 3 Months | Gross (+++) | 0 Participants |
| Hamstring (HT) | Number of Participants With Each Pivot Shift Grade | 2-Years | Gross (+++) | 1 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 3 Months | Gross (+++) | 0 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 6 Months | Equal | 66 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 6 Months | Glide (+) | 39 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 6 Months | Clunk (++) | 2 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 2-Years | Gross (+++) | 1 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 6 Months | Gross (+++) | 0 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 5-Years | Clunk (++) | 22 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 1-Year | Equal | 53 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 1-Year | Glide (+) | 41 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 5-Years | Equal | 30 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 1-Year | Clunk (++) | 7 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 5-Years | Gross (+++) | 1 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 1-Year | Gross (+++) | 1 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | Baseline | Equal | 0 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 2-Years | Equal | 38 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | Baseline | Glide (+) | 9 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 5-Years | Glide (+) | 50 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | Baseline | Clunk (++) | 99 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | Baseline | Gross (+++) | 2 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 2-Years | Glide (+) | 49 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 3 Months | Equal | 80 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 3 Months | Glide (+) | 25 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 3 Months | Clunk (++) | 2 Participants |
| Double-Bundle (DB) | Number of Participants With Each Pivot Shift Grade | 2-Years | Clunk (++) | 19 Participants |
Secondary
Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures
* COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (\>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy. * PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a complete traumatic rerupture. Confirmed by MR or diagnostic arthroscopy. * TRAUMATIC RE-INJURY - combined total of complete traumatic re-ruptures and partial traumatic tears. * ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer.
Time frame: Minimum 2-year Follow-up, 5-Year Follow-up, 10-Year Follow-up
Population: There were 110 participants randomized to each study group. At 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patellar Tendon (PT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | No re-injury or failure | 91 Participants |
| Patellar Tendon (PT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | Complete Traumatic Re-rupture | 3 Participants |
| Patellar Tendon (PT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | Partial Traumatic Tear | 0 Participants |
| Patellar Tendon (PT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | Atraumatic Graft Failure | 16 Participants |
| Patellar Tendon (PT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | No re-injury or failure | 92 Participants |
| Patellar Tendon (PT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | Complete Traumatic Re-rupture | 4 Participants |
| Patellar Tendon (PT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | Partial Traumatic Tear | 0 Participants |
| Patellar Tendon (PT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | Atraumatic Graft Failure | 7 Participants |
| Hamstring (HT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | Partial Traumatic Tear | 5 Participants |
| Hamstring (HT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | Partial Traumatic Tear | 5 Participants |
| Hamstring (HT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | Atraumatic Graft Failure | 17 Participants |
| Hamstring (HT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | No re-injury or failure | 80 Participants |
| Hamstring (HT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | Complete Traumatic Re-rupture | 11 Participants |
| Hamstring (HT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | No re-injury or failure | 81 Participants |
| Hamstring (HT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | Complete Traumatic Re-rupture | 7 Participants |
| Hamstring (HT) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | Atraumatic Graft Failure | 9 Participants |
| Double-Bundle (DB) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | Partial Traumatic Tear | 4 Participants |
| Double-Bundle (DB) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | Complete Traumatic Re-rupture | 7 Participants |
| Double-Bundle (DB) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | No re-injury or failure | 79 Participants |
| Double-Bundle (DB) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | Minimum 2-Year Follow-up | Atraumatic Graft Failure | 20 Participants |
| Double-Bundle (DB) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | Partial Traumatic Tear | 6 Participants |
| Double-Bundle (DB) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | Complete Traumatic Re-rupture | 11 Participants |
| Double-Bundle (DB) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | No re-injury or failure | 76 Participants |
| Double-Bundle (DB) | Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 5-Year Follow-up | Atraumatic Graft Failure | 14 Participants |
Secondary
Proportion of Patients With Moderate or Severe Kneeling Pain
Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions.
Time frame: Baseline, 2 and 5 years post-operatively
Population: At 2 and 5-year follow-up, outcome data was not collected on all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patellar Tendon (PT) | Proportion of Patients With Moderate or Severe Kneeling Pain | 2 Years | 17 Participants |
| Patellar Tendon (PT) | Proportion of Patients With Moderate or Severe Kneeling Pain | Baseline | 29 Participants |
| Patellar Tendon (PT) | Proportion of Patients With Moderate or Severe Kneeling Pain | 5 Years | 10 Participants |
| Hamstring (HT) | Proportion of Patients With Moderate or Severe Kneeling Pain | 2 Years | 9 Participants |
| Hamstring (HT) | Proportion of Patients With Moderate or Severe Kneeling Pain | Baseline | 29 Participants |
| Hamstring (HT) | Proportion of Patients With Moderate or Severe Kneeling Pain | 5 Years | 4 Participants |
| Double-Bundle (DB) | Proportion of Patients With Moderate or Severe Kneeling Pain | Baseline | 18 Participants |
| Double-Bundle (DB) | Proportion of Patients With Moderate or Severe Kneeling Pain | 5 Years | 2 Participants |
| Double-Bundle (DB) | Proportion of Patients With Moderate or Severe Kneeling Pain | 2 Years | 4 Participants |
Secondary
Radiographic (X-ray) Changes
The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.
Time frame: Baseline, 2 and 5 years post-operatively
Secondary
Return to Pre-injury Tegner Activity Level
Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)).
Time frame: 1, 2 and 5 years post-operatively
Population: There were 110 participants randomized to each study group. At 1-, 2- and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patellar Tendon (PT) | Return to Pre-injury Tegner Activity Level | 2 Years | 44 Participants |
| Patellar Tendon (PT) | Return to Pre-injury Tegner Activity Level | 1 Year | 27 Participants |
| Patellar Tendon (PT) | Return to Pre-injury Tegner Activity Level | 5 Years | 35 Participants |
| Hamstring (HT) | Return to Pre-injury Tegner Activity Level | 2 Years | 43 Participants |
| Hamstring (HT) | Return to Pre-injury Tegner Activity Level | 1 Year | 33 Participants |
| Hamstring (HT) | Return to Pre-injury Tegner Activity Level | 5 Years | 41 Participants |
| Double-Bundle (DB) | Return to Pre-injury Tegner Activity Level | 1 Year | 28 Participants |
| Double-Bundle (DB) | Return to Pre-injury Tegner Activity Level | 5 Years | 41 Participants |
| Double-Bundle (DB) | Return to Pre-injury Tegner Activity Level | 2 Years | 36 Participants |
Secondary
Skin-to-Skin Operative Times
Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure
Time frame: During surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patellar Tendon (PT) | Skin-to-Skin Operative Times | 75.3 Minutes | Standard Deviation 14.7 |
| Hamstring (HT) | Skin-to-Skin Operative Times | 67.8 Minutes | Standard Deviation 14.6 |
| Double-Bundle (DB) | Skin-to-Skin Operative Times | 88.0 Minutes | Standard Deviation 14.9 |
Other Pre-specified
Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome)
All complications/adverse events that occurred within the first two-years post-operatively. See Adverse Events section for results of this outcome.
Time frame: 2 years post-operatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Stiffness | 4 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Superficial wound infection | 0 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Chondral lesion | 1 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Failed meniscal repair | 2 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Deep wound infection | 1 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Hamstring injury | 1 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Tibial periostitis | 1 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Stitch abscess | 2 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Cellulitis | 0 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Meniscal cyst | 1 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Patellar tendinopathy | 1 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Persistent effusion / inflammation | 1 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Sensory nerve problems | 4 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Wound dehiscence | 1 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Hardware issues | 0 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Massive pulmonary embolism | 0 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Deep vein thrombosis | 0 Participants |
| Patellar Tendon (PT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Septic arthritis | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Septic arthritis | 1 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Deep wound infection | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Meniscal cyst | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Sensory nerve problems | 1 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Superficial wound infection | 2 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Hardware issues | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Massive pulmonary embolism | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Chondral lesion | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Patellar tendinopathy | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Deep vein thrombosis | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Failed meniscal repair | 6 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Cellulitis | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Wound dehiscence | 0 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Stiffness | 2 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Stitch abscess | 1 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Persistent effusion / inflammation | 2 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Hamstring injury | 6 Participants |
| Hamstring (HT) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Tibial periostitis | 2 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Hamstring injury | 12 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Tibial periostitis | 4 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Stitch abscess | 0 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Hardware issues | 0 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Cellulitis | 3 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Septic arthritis | 0 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Meniscal cyst | 0 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Patellar tendinopathy | 0 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Massive pulmonary embolism | 1 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Persistent effusion / inflammation | 5 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Deep wound infection | 0 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Superficial wound infection | 2 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Sensory nerve problems | 3 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Chondral lesion | 1 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Failed meniscal repair | 4 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Stiffness | 3 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Wound dehiscence | 1 Participants |
| Double-Bundle (DB) | Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) | Deep vein thrombosis | 1 Participants |