Trial · NCT07909928
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Osteochondral Allograft Incorporation Assessed by MRI | 6 months after surgery | Osteochondral allograft incorporation will be assessed using magnetic resonance imaging (MRI) at 6 months after surgery. MRI findings will be evaluated using the Osteochondral Allograft MRI Scoring System (OCAMRISS) and other radiographic indicators of graft incorporation. Results will be summarized descriptively. |
| Secondary | Osteochondral Allograft Incorporation at 12 Weeks | 12 weeks after surgery | Osteochondral allograft incorporation will be assessed using MRI at 12 weeks after surgery. MRI findings will be evaluated using OCAMRISS and other radiographic indicators of graft incorporation and summarized descriptively. |
| Secondary | Osteochondral Allograft Incorporation at 12 Months | 12 months after surgery, if clinically indicated | Additional MRI evaluation will be performed at 12 months for participants with incomplete graft incorporation at the 6-month assessment. Graft incorporation will be assessed using OCAMRISS and other MRI indicators of graft healing. |
| Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline, 1 week, 6 weeks, 12 weeks, 6 months, and 1 year after surgery | Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively. |
| Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline | Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively. |
| Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | 1 week | Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively. |
| Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 weeks | Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively. |
| Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | 12 weeks | Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively. |
| Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 months | Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively. |
| Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | 1 year after surgery | Patient-reported knee symptoms and function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and scheduled postoperative follow-up visits. Changes in KOOS scores over time will be summarized descriptively. |
| Secondary | Change in Pain Measured by Visual Analog Scale (VAS) | Baseline | Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively. |
| Secondary | Change in Pain Measured by Visual Analog Scale (VAS) | 1 week | Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively. |
| Secondary | Change in Pain Measured by Visual Analog Scale (VAS) | 6 weeks | Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively. |
| Secondary | Change in Pain Measured by Visual Analog Scale (VAS) | 12 weeks | Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively. |
| Secondary | Change in Pain Measured by Visual Analog Scale (VAS) | 6 months | Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively. |
| Secondary | Change in Pain Measured by Visual Analog Scale (VAS) | 1 year after surgery | Patient-reported pain will be assessed using a Visual Analog Scale (VAS) at baseline and scheduled postoperative follow-up visits. Changes in pain ratings over time will be summarized descriptively. |
| Secondary | Radiographic Evidence of Graft Incorporation and Healing | Through 1 year after surgery | Radiographic evidence of osteochondral allograft incorporation and healing will be evaluated using standard-of-care postoperative radiographs obtained throughout the follow-up period. Radiographic findings will be summarized descriptively. |
| Secondary | Postoperative Complications and Adverse Events | From surgery through 1 year after surgery | Postoperative complications and adverse events related to osteochondral allograft transplantation and biologic augmentation will be collected through clinical follow-up and review of medical records during the 1-year postoperative period. |
| Secondary | Subsequent Procedures Related to Index Surgery | From surgery through 1 year after surgery | Subsequent surgical or other procedures related to the index osteochondral allograft transplantation will be recorded during the 1-year postoperative follow-up period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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