Trial Outcomes & Findings for Bridge-Enhanced ACL Repair vs ACL Reconstruction (NCT NCT02664545)
NCT ID: NCT02664545
Last Updated: 2025-12-30
Results Overview
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).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
2 years after surgery
Results posted on
2025-12-30
Participant Flow
The protocol enrollment is the number of participants who had surgery, not the number of participants who were evaluated at baseline.
Participant milestones
| Measure |
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.
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
35
|
|
Overall Study
Surgery
|
65
|
35
|
|
Overall Study
COMPLETED
|
58
|
32
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bridge-Enhanced ACL Repair vs ACL Reconstruction
Baseline characteristics by cohort
| Measure |
Bridge-Enhanced ACL Repair (BEAR)
n=65 Participants
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.
|
Tendon Graft
n=35 Participants
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)
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
43 Participants
n=174 Participants
|
21 Participants
n=166 Participants
|
64 Participants
n=167 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=174 Participants
|
14 Participants
n=166 Participants
|
36 Participants
n=167 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Age, Continuous
|
19.5 years
STANDARD_DEVIATION 5.2 • n=174 Participants
|
19.8 years
STANDARD_DEVIATION 5.3 • n=166 Participants
|
19.6 years
STANDARD_DEVIATION 5.2 • n=167 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=174 Participants
|
19 Participants
n=166 Participants
|
56 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=174 Participants
|
16 Participants
n=166 Participants
|
44 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=174 Participants
|
35 Participants
n=166 Participants
|
99 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=174 Participants
|
6 Participants
n=166 Participants
|
12 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=174 Participants
|
27 Participants
n=166 Participants
|
83 Participants
n=167 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
|
Body Mass Index (BMI)
|
24.7 kg/m^2
STANDARD_DEVIATION 3.8 • n=174 Participants
|
23.5 kg/m^2
STANDARD_DEVIATION 4.6 • n=166 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 4.1 • n=167 Participants
|
PRIMARY outcome
Timeframe: 2 years after surgeryPopulation: Multiple imputation used for missing data.
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).
Outcome measures
| Measure |
Tendon Graft
n=35 Participants
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)
|
Bridge-Enhanced ACL Repair (BEAR)
n=65 Participants
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.
|
|---|---|---|
|
International Knee Documentation Committee (IKDC) Subjective
|
84.6 score on a scale
Standard Deviation 13.3
|
88.6 score on a scale
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: 2 years after surgeryPopulation: Multiple imputation used for missing data.
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.
Outcome measures
| Measure |
Tendon Graft
n=35 Participants
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)
|
Bridge-Enhanced ACL Repair (BEAR)
n=65 Participants
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.
|
|---|---|---|
|
Instrumented Anteroposterior (AP) Laxity Testing
|
1.8 mm
Standard Deviation 2.8
|
1.7 mm
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 6 monthsMeasured 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.
Outcome measures
| Measure |
Tendon Graft
n=35 Participants
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)
|
Bridge-Enhanced ACL Repair (BEAR)
n=65 Participants
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.
|
|---|---|---|
|
Prone Hamstring Strength at 6 Months
|
59.1 percentage of non injured knee
Standard Deviation 21.3
|
93.3 percentage of non injured knee
Standard Deviation 23.6
|
SECONDARY outcome
Timeframe: 6 monthsThis 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.
Outcome measures
| Measure |
Tendon Graft
n=35 Participants
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)
|
Bridge-Enhanced ACL Repair (BEAR)
n=65 Participants
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.
|
|---|---|---|
|
Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.
|
58.9 score on a scale
Standard Deviation 24.1
|
71.5 score on a scale
Standard Deviation 19.5
|
Adverse Events
Bridge-Enhanced ACL Repair (BEAR)
Serious events: 16 serious events
Other events: 34 other events
Deaths: 0 deaths
Tendon Graft
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bridge-Enhanced ACL Repair (BEAR)
n=65 participants at risk
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.
|
Tendon Graft
n=35 participants at risk
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)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
ACL Injury- No Surgery
|
1.5%
1/65 • Number of events 1 • Adverse Events measured at 2-year Primary Endpoint.
|
0.00%
0/35 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
ACL Second Surgery
|
1.5%
1/65 • Number of events 1 • Adverse Events measured at 2-year Primary Endpoint.
|
2.9%
1/35 • Number of events 1 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
ACL Second Surgery with Meniscus
|
12.3%
8/65 • Number of events 8 • Adverse Events measured at 2-year Primary Endpoint.
|
2.9%
1/35 • Number of events 1 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis-Surgery
|
0.00%
0/65 • Adverse Events measured at 2-year Primary Endpoint.
|
5.7%
2/35 • Number of events 2 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain-Surgery
|
1.5%
1/65 • Number of events 1 • Adverse Events measured at 2-year Primary Endpoint.
|
5.7%
2/35 • Number of events 2 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
Meniscus-Surgery
|
10.8%
7/65 • Number of events 11 • Adverse Events measured at 2-year Primary Endpoint.
|
5.7%
2/35 • Number of events 2 • Adverse Events measured at 2-year Primary Endpoint.
|
Other adverse events
| Measure |
Bridge-Enhanced ACL Repair (BEAR)
n=65 participants at risk
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.
|
Tendon Graft
n=35 participants at risk
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)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
ACL Injury- No Surgery
|
9.2%
6/65 • Number of events 6 • Adverse Events measured at 2-year Primary Endpoint.
|
5.7%
2/35 • Number of events 2 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
Injury- Knee Other No Surgery
|
9.2%
6/65 • Number of events 6 • Adverse Events measured at 2-year Primary Endpoint.
|
0.00%
0/35 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain- No Surgery
|
15.4%
10/65 • Number of events 11 • Adverse Events measured at 2-year Primary Endpoint.
|
11.4%
4/35 • Number of events 4 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
Meniscus- No Surgery
|
1.5%
1/65 • Number of events 1 • Adverse Events measured at 2-year Primary Endpoint.
|
5.7%
2/35 • Number of events 2 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
Range of Motion Decreased
|
10.8%
7/65 • Number of events 7 • Adverse Events measured at 2-year Primary Endpoint.
|
5.7%
2/35 • Number of events 2 • Adverse Events measured at 2-year Primary Endpoint.
|
|
Musculoskeletal and connective tissue disorders
Infection Knee-Superficial No Abx
|
6.2%
4/65 • Number of events 4 • Adverse Events measured at 2-year Primary Endpoint.
|
2.9%
1/35 • Number of events 1 • Adverse Events measured at 2-year Primary Endpoint.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place