An interventional study of BioBrace® Reinforced BioInductive Implant in Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, sponsored by Yonsei University. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
This prospective, single-center, single-arm observational cohort study aims to evaluate the clinical, radiological, and arthroscopic outcomes and safety of primary anterior cruciate ligament (ACL) reconstruction augmented with the BioBrace® Reinforced BioInductive Implant. A total of 30 patients who decided to undergo BioBrace-augmented ACL reconstruction in routine clinical practice will be followed for up to 24 months postoperatively. Knee stability, graft maturation via MRI and second-look arthroscopy, patient-reported outcomes, and complications will be assessed.
The BioBrace® Reinforced BioInductive Implant is a bioresorbable scaffold composed of type I bovine collagen and poly-L-lactic acid (PLLA) microfilaments designed to provide mechanical reinforcement and facilitate tissue remodeling during graft healing. In this study, 30 skeletal mature patients receiving BioBrace-augmented primary ACL reconstruction will be evaluated preoperatively and postoperatively at 3, 6, 12, and 24 months. Objective anterior and rotational stability will be measured using the KT-2000 arthrometer (side-to-side difference, SSD) and the pivot-shift test. Patient-reported outcome measures (VAS for pain, IKDC subjective score, Lysholm score, and Tegner activity scale) will be recorded. Graft maturation will be assessed via 12-month postoperative MRI (measuring signal-to-noise quotient, SNQ, and structural integrity) and second-look arthroscopy during tibial implant removal at 24 months (using Ahn's Graft Maturation Score, GMS). Adverse events, graft failure/re-tear, and reoperation rates will be monitored throughout the 24-month follow-up period.
523 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 170 are open to participants now.
This study's planned enrollment of 30 is below the median of 56 across 380 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Yonsei University is the lead sponsor of 1,417 studies on the registry; 240 are open to participants now.
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Exclusion Criteria:
Patients undergoing primary anterior cruciate ligament (ACL) reconstruction augmented with the BioBrace® Reinforced BioInductive Implant (5 x 250 mm). The implant is folded and incorporated alongside the prepared ACL graft, then fixed into the femoral and tibial bone tunnels. Concomitant meniscal surgery (repair or partial meniscectomy) or anterolateral ligament (ALL) reconstruction is performed when clinically indicated.
Device: BioBrace® Reinforced BioInductive Implant
BioBrace® Reinforced BioInductive Implant (5 x 250 mm; CONMED Corporation) is used as an augment for primary ACL reconstruction. The bioinductive scaffold is whipstitched at both ends, folded in half, positioned alongside the autograft/allograft tendon, and passed through femoral and tibial tunnels for standard fixation to reinforce early mechanical stability and facilitate graft maturation.
Also known as: BioBrace, Bioinductive collagen-PLLA implant, BioBrace-augmented primary ACL reconstruction
Side-to-Side Difference in Anterior Knee Laxity Measured by KT-2000 Arthrometer
Anterior knee laxity is measured as the side-to-side difference (SSD, in millimeters) in anterior tibial translation between the injured and contralateral uninjured knee using the KT-2000 arthrometer under a 30-lb (134 N) anterior load at 30 degrees of knee flexion.
Time frame: Up to 24 months postoperatively (assessed at preoperative baseline, 3, 6, 12, and 24 months after surgery)
Rotational Knee Stability Evaluated by Pivot-Shift Test
Rotational knee stability evaluated by the manual pivot-shift test and graded according to International Knee Documentation Committee (IKDC) guidelines: Grade 0 (normal/equal), Grade 1 (glide), Grade 2 (clunk), Grade 3 (gross).
Time frame: Up to 24 months postoperatively (assessed at preoperative baseline, 3, 6, 12, and 24 months after surgery)
Graft Signal-to-Noise Quotient (SNQ) on Postoperative MRI
Graft maturation and signal intensity quantified by the signal-to-noise quotient (SNQ) on sagittal-oblique proton density-weighted fat-suppressed MRI images, calculated using the posterior cruciate ligament (PCL) and background noise.
Time frame: 12 months after surgery
Structural Integrity and Graft Continuity on Postoperative MRI
Evaluation of the reconstructed ACL graft structural continuity, categorized as intact, partial tear, or complete tear based on 12-month postoperative MRI findings.
Time frame: 12 months after surgery
Knee Pain Assessed by Visual Analog Scale (VAS)
Patient-reported pain severity measured on a Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Preoperative baseline, and 6, 12, and 24 months after surgery
International Knee Documentation Committee (IKDC) Subjective Knee Score
Self-reported knee symptoms, function, and sports activities assessed using the IKDC Subjective Knee Evaluation Form. Scores range from 0 to 100, where higher scores indicate higher levels of function and lower levels of symptoms.
Time frame: Preoperative baseline, and 6, 12, and 24 months after surgery
Lysholm Knee Scoring Scale
Evaluates knee function and daily activity symptoms (limp, support, locking, instability, pain, swelling, stair climbing, squatting). Scores range from 0 to 100, with higher scores reflecting better knee function.
Time frame: Preoperative baseline, and 6, 12, and 24 months after surgery
Tegner Activity Scale
Assesses the patient's activity and sports participation level. Scores range from 0 (sick leave or disability due to knee injury) to 10 (participation in competitive sports at national/international elite level). Higher scores indicate higher physical activity levels.
Time frame: Preoperative baseline, and 6, 12, and 24 months after surgery
No study locations are listed for this record.
Plan to share: Undecided — The plan to share individual participant data with other researchers has not yet been determined.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 241 non-industry interventional studies with no phase under Anterior Cruciate Ligament Injuries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 70. This study's planned 24 months is below that.
Counting every sponsor, half of 248 studies reached it within 30 months; a quarter within 14 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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