Trial · NCT07906860
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
NCT07906860, Not applicable, Not yet recruiting, Yonsei University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction. Trials, record NCT07906860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07906860
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
- NCT number
- NCT07906860
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Yonsei University
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
- Interventions
- BioBrace® Reinforced BioInductive Implant
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Side-to-Side Difference in Anterior Knee Laxity Measured by KT-2000 Arthrometer | Up to 24 months postoperatively (assessed at preoperative baseline, 3, 6, 12, and 24 months after surgery) | 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. |
| Primary | Rotational Knee Stability Evaluated by Pivot-Shift Test | Up to 24 months postoperatively (assessed at preoperative baseline, 3, 6, 12, and 24 months after surgery) | 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). |
| Secondary | Graft Signal-to-Noise Quotient (SNQ) on Postoperative MRI | 12 months after surgery | 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. |
| Secondary | Structural Integrity and Graft Continuity on Postoperative MRI | 12 months after surgery | Evaluation of the reconstructed ACL graft structural continuity, categorized as intact, partial tear, or complete tear based on 12-month postoperative MRI findings. |
| Secondary | Knee Pain Assessed by Visual Analog Scale (VAS) | Preoperative baseline, and 6, 12, and 24 months after surgery | Patient-reported pain severity measured on a Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). |
| Secondary | International Knee Documentation Committee (IKDC) Subjective Knee Score | Preoperative baseline, and 6, 12, and 24 months after surgery | 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. |
| Secondary | Lysholm Knee Scoring Scale | Preoperative baseline, and 6, 12, and 24 months after surgery | 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. |
| Secondary | Tegner Activity Scale | Preoperative baseline, and 6, 12, and 24 months after surgery | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07906860
GET https://conductscience.org/api/trials/v1/NCT07906860/registered