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The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridge-Enhanced ACL Repair (BEAR) | Experimental | The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into. |
|
| Tendon Graft | Active Comparator | ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEAR Scaffold | Device | A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament. |
|
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee (IKDC) Subjective | This is a survey taken by patients to report how their knee is working for them. The IKDC is graded by adding the results and converting the result to a number on a scale from 0 to 100. Scores range from 0 (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 2 years after surgery |
| Instrumented Anteroposterior (AP) Laxity Testing | This is a test of how stable the knee is. The anteroposterior (AP) knee laxity will be determined using a KT arthrometer at the 30lb (130N) setting on both knees of the subject at six months and 1, 2, 6 and 10 years after surgery (see Appendix C). Both sides will be covered with a sleeve so the licensed examiner cannot tell which is the operated knee or which procedure the patient had. Values for both knees will be recorded. For knee laxity, a difference of 2.0 mm in the side-to-side difference measurements at 2 years after surgery, the primary analysis, for the patients in the bridge-enhanced repair group vs. the ACL reconstruction group will be considered clinically significant. | 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prone Hamstring Strength at 6 Months | Measured by a hand-held dynamometer on both the involved and contralateral knees, measured as injured knee as percent of non injured knee. The subject lies on their stomach and flexes their leg. The trainer puts the dynamometer near the ankle in the direction of extension. The subject pushes as hard as they can in the flexion direction, against the dynamometer. Ratio is calculated as the measurement of injured knee over measurement of non-injured knee. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Meng Yen, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42293045 | Derived | Pruneski JA, Kaushal SG, Ecklund K, Kramer DE, Yen YM, Micheli LJ, Fleming BC, Murray MM, Kiapour AM. Magnetic Resonance Imaging Assessment of Bridge-Enhanced ACL Restoration: An Imaging Atlas of Morphological Features and Healing Trajectories. Orthop J Sports Med. 2026 Jun 10;14(6):23259671261445974. doi: 10.1177/23259671261445974. eCollection 2026 Jun. | |
| 36263311 |
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The protocol enrollment is the number of participants who had surgery, not the number of participants who were evaluated at baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bridge-Enhanced ACL Repair (BEAR) | The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into. BEAR Scaffold: A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament. |
| FG001 | Tendon Graft | ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL. Tendon Graft: A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data analyzed for N=100 subjects screened.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bridge-Enhanced ACL Repair (BEAR) | The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into. BEAR Scaffold: A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | International Knee Documentation Committee (IKDC) Subjective | This is a survey taken by patients to report how their knee is working for them. The IKDC is graded by adding the results and converting the result to a number on a scale from 0 to 100. Scores range from 0 (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | Multiple imputation used for missing data. | Posted | Mean | Standard Deviation | score on a scale | 2 years after surgery |
|
Adverse Events measured at 2-year Primary Endpoint.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bridge-Enhanced ACL Repair (BEAR) | The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into. BEAR Scaffold: A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACL Injury- No Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACL Injury- No Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rita Paparazzo | Miach Orthopaedics | 1-800-590-6995 x107 | rpaparazzo@miachortho.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2021 | Dec 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2019 | Dec 12, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Tendon Graft | Procedure | A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) |
|
| 6 months |
| Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months. | This is a survey taken by patients to report how confident they are in returning to sports after the injury. The 12 questions on the ACL-RSI scale ask about the psychological effects of returning to sports. The ACL-RSI items are graded using an NRS (numeric rating scale) from 0 to 10. It has three domains: risk appraisal, confidence, and emotions. A total score between 0 and 100 is calculated by adding and averaging the scores for each item. Greater psychological preparation is indicated by higher scores. | 6 months |
| Menghini D, Kaushal SG, Flannery SW, Ecklund K; BEAR Trial Team; Murray MM, Fleming BC, Kiapour AM, Proffen B, Sant N, Portilla G, Sanborn R, Freiberger C, Henderson R, Barnett S, Yen YM, Kramer DE, Micheli LJ. Changes in the Cross-Sectional Profile of Treated Anterior Cruciate Ligament Within 2 Years After Surgery. Orthop J Sports Med. 2022 Oct 14;10(10):23259671221127326. doi: 10.1177/23259671221127326. eCollection 2022 Oct. |
| 35155707 | Derived | Sanborn RM, Badger GJ; BEAR Trial Team; Yen YM, Murray MM, Christino MA, Proffen B, Sant N, Barnett S, Fleming BC, Kramer DE, Micheli LJ. Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial. Orthop J Sports Med. 2022 Feb 9;10(2):23259671211070542. doi: 10.1177/23259671211070542. eCollection 2022 Feb. |
| 34988237 | Derived | Barnett SC, Murray MM, Flannery SW; BEAR Trial Team; Menghini D, Fleming BC, Kiapour AM, Proffen B, Sant N, Portilla G, Sanborn R, Freiberger C, Henderson R, Ecklund K, Yen YM, Kramer D, Micheli L. ACL Size, but Not Signal Intensity, Is Influenced by Sex, Body Size, and Knee Anatomy. Orthop J Sports Med. 2021 Dec 17;9(12):23259671211063836. doi: 10.1177/23259671211063836. eCollection 2021 Dec. |
| 34778483 | Derived | Barnett SC, Murray MM, Badger GJ; BEAR Trial Team; Yen YM, Kramer DE, Sanborn R, Kiapour A, Proffen B, Sant N, Fleming BC, Micheli LJ. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. eCollection 2021 Nov. |
| 32298131 | Derived | Murray MM, Fleming BC, Badger GJ; BEAR Trial Team; Freiberger C, Henderson R, Barnett S, Kiapour A, Ecklund K, Proffen B, Sant N, Kramer DE, Micheli LJ, Yen YM. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial. Am J Sports Med. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Epub 2020 Apr 16. |
| 30986359 | Derived | Murray MM, Kiapour AM, Kalish LA, Ecklund K; BEAR Trial Team; Freiberger C, Henderson R, Kramer D, Micheli L, Yen YM, Fleming BC. Predictors of Healing Ligament Size and Magnetic Resonance Signal Intensity at 6 Months After Bridge-Enhanced Anterior Cruciate Ligament Repair. Am J Sports Med. 2019 May;47(6):1361-1369. doi: 10.1177/0363546519836087. Epub 2019 Apr 15. |
| BG001 |
| Tendon Graft |
ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL. Tendon Graft: A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Tendon Graft | ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL. Tendon Graft: A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) |
|
|
| Primary | Instrumented Anteroposterior (AP) Laxity Testing | This is a test of how stable the knee is. The anteroposterior (AP) knee laxity will be determined using a KT arthrometer at the 30lb (130N) setting on both knees of the subject at six months and 1, 2, 6 and 10 years after surgery (see Appendix C). Both sides will be covered with a sleeve so the licensed examiner cannot tell which is the operated knee or which procedure the patient had. Values for both knees will be recorded. For knee laxity, a difference of 2.0 mm in the side-to-side difference measurements at 2 years after surgery, the primary analysis, for the patients in the bridge-enhanced repair group vs. the ACL reconstruction group will be considered clinically significant. | Multiple imputation used for missing data. | Posted | Mean | Standard Deviation | mm | 2 years after surgery |
|
|
|
| Secondary | Prone Hamstring Strength at 6 Months | Measured by a hand-held dynamometer on both the involved and contralateral knees, measured as injured knee as percent of non injured knee. The subject lies on their stomach and flexes their leg. The trainer puts the dynamometer near the ankle in the direction of extension. The subject pushes as hard as they can in the flexion direction, against the dynamometer. Ratio is calculated as the measurement of injured knee over measurement of non-injured knee. | Posted | Mean | Standard Deviation | percentage of non injured knee | 6 months |
|
|
|
| Secondary | Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months. | This is a survey taken by patients to report how confident they are in returning to sports after the injury. The 12 questions on the ACL-RSI scale ask about the psychological effects of returning to sports. The ACL-RSI items are graded using an NRS (numeric rating scale) from 0 to 10. It has three domains: risk appraisal, confidence, and emotions. A total score between 0 and 100 is calculated by adding and averaging the scores for each item. Greater psychological preparation is indicated by higher scores. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 0 |
| 65 |
| 16 |
| 65 |
| 34 |
| 65 |
| EG001 | Tendon Graft | ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL. Tendon Graft: A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) | 0 | 35 | 5 | 35 | 11 | 35 |
| ACL Second Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ACL Second Surgery with Meniscus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthrofibrosis-Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee Pain-Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Meniscus-Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Injury- Knee Other No Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee Pain- No Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Meniscus- No Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Range of Motion Decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Infection Knee-Superficial No Abx | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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