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The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure

View Article: PubMed Central - PubMed

ABSTRACT

Background:: This study assessed the safety of the newly developed bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR), which involves suture repair of the ligament combined with a bioactive scaffold to bridge the gap between the torn ligament ends. As the intra-articular environment is complex in its response to implanted materials, this study was designed to determine whether there would be a significant rate of adverse reaction to the implanted scaffold.

Hypothesis:: The primary hypothesis was that the implanted scaffold would not result in a deep joint infection (arthrocentesis with positive culture) or significant inflammation (clinical symptoms justifying arthrocentesis but negative culture). The secondary hypotheses were that patients treated with BEAR would have early postoperative outcomes that were similar to patients treated with ACL reconstruction with an autologous hamstring graft.

Study design:: Cohort study; Level of evidence, 2.

Methods:: A total of 20 patients were enrolled in this nonrandomized, first-in-human study. Ten patients received BEAR treatment and 10 received a hamstring autograft ACL reconstruction. The BEAR procedure was performed by augmenting a suture repair with a proprietary scaffold, the BEAR scaffold, placed in between the torn ends of the ACL at the time of suture repair. The BEAR scaffold is to our knowledge the only device that fills the gap between the torn ligament ends to have current Investigational Device Exemption approval from the Food and Drug Administration. Ten milliliters of autologous whole blood were added to the scaffold prior to wound closure. Outcomes were assessed at 3 months postoperatively. The outcomes measures included postoperative pain, muscle atrophy, loss of joint range of motion, and implant failure (designated by an International Knee Documentation Committee grade C or D Lachman test and/or an absence of continuous ACL tissue on magnetic resonance images).

Results:: There were no joint infections or signs of significant inflammation in either group. There were no differences between groups in effusion or pain, and no failures by Lachman examination criteria (BEAR, 8 grade A and 2 grade B; ACL reconstruction, 10 grade A). Magnetic resonance images from all of the BEAR and ACL-reconstructed patients demonstrated a continuous ACL or intact graft. In addition, hamstring strength at 3 months was significantly better in the BEAR group than in the hamstring autograft group (mean ± SD: 77.9% ± 14.6% vs 55.9% ± 7.8% of the contralateral side; P < .001).

Conclusion:: The results of this study suggest that the BEAR procedure may have a rate of adverse reactions low enough to warrant a study of efficacy in a larger group of patients.

No MeSH data available.


CONSORT 2010 flow diagram. *The total number of patients not meeting inclusion criteria totals to greater than 214, as some patients met more than 1 exclusion criterion. ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair.
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fig1-2325967116672176: CONSORT 2010 flow diagram. *The total number of patients not meeting inclusion criteria totals to greater than 214, as some patients met more than 1 exclusion criterion. ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair.

Mentions: A total of 242 patients presenting with an ACL injury were screened for participation in this study (Figure 1). Patients were identified as possible candidates if they scheduled an appointment in our sports medicine division with a new knee injury and had an MRI confirming an ACL tear or if they contacted our research coordinator after hearing about the study. Of the 242 patients screened, 22 were enrolled (Figure 1), of which 2 were excluded before surgery: 1 due to a history of corticosteroid use not discovered in the initial enrollment meeting and the second patient elected to move to Florida for school. The primary reason for exclusion prior to enrollment was patient age (n = 181 patients).


The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure
CONSORT 2010 flow diagram. *The total number of patients not meeting inclusion criteria totals to greater than 214, as some patients met more than 1 exclusion criterion. ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License 1 - License 2 - License 3
Show All Figures
getmorefigures.php?uid=PMC5120682&req=5

fig1-2325967116672176: CONSORT 2010 flow diagram. *The total number of patients not meeting inclusion criteria totals to greater than 214, as some patients met more than 1 exclusion criterion. ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair.
Mentions: A total of 242 patients presenting with an ACL injury were screened for participation in this study (Figure 1). Patients were identified as possible candidates if they scheduled an appointment in our sports medicine division with a new knee injury and had an MRI confirming an ACL tear or if they contacted our research coordinator after hearing about the study. Of the 242 patients screened, 22 were enrolled (Figure 1), of which 2 were excluded before surgery: 1 due to a history of corticosteroid use not discovered in the initial enrollment meeting and the second patient elected to move to Florida for school. The primary reason for exclusion prior to enrollment was patient age (n = 181 patients).

View Article: PubMed Central - PubMed

ABSTRACT

Background:: This study assessed the safety of the newly developed bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR), which involves suture repair of the ligament combined with a bioactive scaffold to bridge the gap between the torn ligament ends. As the intra-articular environment is complex in its response to implanted materials, this study was designed to determine whether there would be a significant rate of adverse reaction to the implanted scaffold.

Hypothesis:: The primary hypothesis was that the implanted scaffold would not result in a deep joint infection (arthrocentesis with positive culture) or significant inflammation (clinical symptoms justifying arthrocentesis but negative culture). The secondary hypotheses were that patients treated with BEAR would have early postoperative outcomes that were similar to patients treated with ACL reconstruction with an autologous hamstring graft.

Study design:: Cohort study; Level of evidence, 2.

Methods:: A total of 20 patients were enrolled in this nonrandomized, first-in-human study. Ten patients received BEAR treatment and 10 received a hamstring autograft ACL reconstruction. The BEAR procedure was performed by augmenting a suture repair with a proprietary scaffold, the BEAR scaffold, placed in between the torn ends of the ACL at the time of suture repair. The BEAR scaffold is to our knowledge the only device that fills the gap between the torn ligament ends to have current Investigational Device Exemption approval from the Food and Drug Administration. Ten milliliters of autologous whole blood were added to the scaffold prior to wound closure. Outcomes were assessed at 3 months postoperatively. The outcomes measures included postoperative pain, muscle atrophy, loss of joint range of motion, and implant failure (designated by an International Knee Documentation Committee grade C or D Lachman test and/or an absence of continuous ACL tissue on magnetic resonance images).

Results:: There were no joint infections or signs of significant inflammation in either group. There were no differences between groups in effusion or pain, and no failures by Lachman examination criteria (BEAR, 8 grade A and 2 grade B; ACL reconstruction, 10 grade A). Magnetic resonance images from all of the BEAR and ACL-reconstructed patients demonstrated a continuous ACL or intact graft. In addition, hamstring strength at 3 months was significantly better in the BEAR group than in the hamstring autograft group (mean ± SD: 77.9% ± 14.6% vs 55.9% ± 7.8% of the contralateral side; P < .001).

Conclusion:: The results of this study suggest that the BEAR procedure may have a rate of adverse reactions low enough to warrant a study of efficacy in a larger group of patients.

No MeSH data available.