Trial · NCT07896954
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analogue Scale change | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | Subjective post-surgical pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. |
| Primary | Pittsburgh Sleep Quality Index (PSQI) | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. |
| Primary | Hospital Anxiety and Depression Scale (HADS) | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | HADS measures anxiety and depression in the medical setting. Higher scores indicate greater anxiety and depression. |
| Primary | EuroQol-5D questionnaire (EQ-5D) | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | EQ-5D-5L is a standardized measure of health-related quality of life. The higher transformed scores, the better HRQoL. |
| Secondary | Visual Analogue Scale for Anxiety (VAS-A) | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | Subjective anxiety rated on a 100-mm line from 0 (no anxiety) to 100 (worst imaginable anxiety). Higher scores indicate greater anxiety. |
| Secondary | Heart rate variability (HRV) | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | Time-domain (SDNN, RMSSD) and frequency-domain (LF, HF power) HRV indices derived from short-term ECG/PPG recordings. Higher RMSSD and HF indicate greater parasympathetic activity. |
| Secondary | Knee injury and Osteoarthritis Outcome Score (KOOS) | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | Patient-reported knee function across five subscales (pain, symptoms, activities of daily living, sport/recreation, knee-related quality of life), each scored 0-100. Higher scores indicate better function. |
| Secondary | Knee range of motion (ROM) | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | Active knee flexion and extension measured in degrees with a goniometer. Larger flexion range indicates better knee mobility. |
| Secondary | Manual muscle testing (MMT) of hamstrings and quadriceps | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | Hamstring and quadriceps strength graded on the 0-5 manual muscle testing scale. Higher grades indicate greater muscle strength. |
| Secondary | Timed Up and Go Test (TUG) | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | Time (seconds) to rise from a chair, walk 3 meters, turn, walk back and sit down. Shorter times indicate better functional mobility. |
| Secondary | 2-Minute Walk Test (2MWT) | Baseline (preoperative) and at 2, 6, and 12 weeks after surgery | Distance (meters) walked in 2 minutes. Longer distances indicate better walking capacity. |
| Secondary | Tampa Scale for Kinesiophobia (TSK-11) | Baseline (preoperative) | 11-item questionnaire assessing fear of movement and re-injury, total score 11-44. Higher scores indicate greater kinesiophobia. Assessed as a predictor of postoperative recovery. |
| Secondary | Pain Catastrophizing Scale (PCS) | Baseline (preoperative) | 13-item questionnaire assessing rumination, magnification and helplessness about pain, total score 0-52. Higher scores indicate greater pain catastrophizing. Assessed as a predictor of postoperative recovery. |
| Secondary | State-Trait Anxiety Inventory (STAI-S/T) | Baseline (preoperative) and 12 weeks after surgery | Two 20-item subscales measuring state and trait anxiety, each scored 20-80. Higher scores indicate greater anxiety. |
| Secondary | Beck Depression Inventory (BDI) | Baseline (preoperative) and 12 weeks after surgery | 21-item self-report measure of depressive symptoms, total score 0-63. Higher scores indicate more severe depressive symptoms. |
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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