Trial · NCT07881445
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IKDC Subjective Knee Evaluation score at 12 months after surgery | 12 months after surgery. Additional protocol measurements occur at 3 and 6 months. | The IKDC Subjective Knee Evaluation score assesses participant-reported knee symptoms and function on a 0-100 scale. Higher scores indicate better function and fewer symptoms. The primary non-inferiority comparison uses the 12-month between-group difference and its 95% confidence interval, with a prespecified margin of 10.3 points. |
| Secondary | Pain visual analog scale | Baseline and 3, 6, and 12 months after surgery | Knee pain assessed using a 10-cm visual analog scale (VAS), recorded from 0 to 10: 0 = no pain; 10 = worst imaginable pain. Higher scores indicate greater pain. Scores and changes from baseline are assessed. |
| Secondary | Lysholm knee score | Baseline and 3, 6, and 12 months after surgery | Patient-reported knee symptoms and function measured using the Lysholm knee score, ranging from 0 to 100; higher scores indicate better knee function. |
| Secondary | Knee injury and Osteoarthritis Outcome Score (KOOS) | Baseline and 3, 6, and 12 months after surgery | The original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS) assesses pain, symptoms, activities of daily living, sport/recreation, and knee-related quality of life. Each of the five subscales is scored separately from 0 to 100; higher scores indicate fewer symptoms and better function. |
| Secondary | MOCART 2.0 knee score | 12 months after surgery | MRI assessment of cartilage repair using the MOCART 2.0 knee score, ranging from 0 to 100; higher scores indicate more favorable repair tissue morphology. |
| Secondary | Subchondral edema assessment | 12 months after surgery | Subchondral edema assessed on MRI using the relevant MOCART 2.0 subscale. |
| Secondary | Presence of subchondral cysts | 12 months after surgery | Presence or absence of subchondral cysts on MRI. |
| Secondary | Presence of subchondral insufficiency fracture | 12 months after surgery | Presence or absence of subchondral insufficiency fracture on MRI. |
| Secondary | ICRS Cartilage Repair Assessment | At second-look arthroscopy during plate removal, planned at 12 months | ICRS Cartilage Repair Assessment at second-look arthroscopy during plate removal in participants with concomitant high tibial osteotomy. Defect filling, integration with adjacent cartilage, and macroscopic appearance are each scored from 0 to 4 and summed to a total of 0 to 12; higher scores indicate better cartilage repair. Overall repair is classified from Grade I (normal) to Grade IV (severely abnormal). |
| Secondary | Kellgren-Lawrence grade | Baseline and 6 and 12 months after surgery | Radiographic osteoarthritis assessed using the Kellgren-Lawrence grade, ranging from 0 to 4; higher grades indicate more severe osteoarthritis. |
| Secondary | Hip-knee-ankle angle | Baseline and 6 and 12 months after surgery | Lower-limb alignment measured as the hip-knee-ankle angle, in degrees, on standing full-length radiographs. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07881445/registered