Trial · NCT07895472
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 | Chronic postsurgical pain | 3 months after surgery | Presence of chronic postsurgical pain (binary) is defined per the definition adopted in International Classification of Diseases version 11; pain develops or increases in intensity after a surgical procedure or a tissue injury, pain persists beyond the healing process (3 months), present either at the surgical/area, or projected onto the innervation area of a nerve, other causes of pain (e.g. pre-existing pain conditions, infection, malignancy) are excluded . |
| Secondary | Moderate-to-severe chronic postsurgical pain | 3, 6, 9, and 12 months after surgery | Presence of chronic postsurgical pain (binary) is defined as per the definition adopted in International Classification of Diseases version 11; mild-to-moderate is defined as pain intensity of ≥4/10 during ambulation over the last week. Pain intensity will be measured on a numeric rating scale of 0-10 where a lower score is better. |
| Secondary | Pain control | Up to 3 months after surgery | Time to achieve good pain control (time-to-event); good pain control will be defined as achieving a state of pain intensity of \<4/10 during ambulation over the past week without the need for daily opioid medication for the operated knee. Pain intensity will be measured on a numeric rating scale of 0-10 where a lower score is better. |
| Secondary | Chronic postsurgical pain | 6, 9, and 12 months after surgery | Presence of chronic postsurgical pain (Binary) is defined per the definition adopted in International Classification of Diseases version 11; pain develops or increases in intensity after a surgical procedure or a tissue injury, pain persists beyond the healing process (3 months), present either at the surgical/area, or projected onto the innervation area of a nerve, other causes of pain (e.g. pre-existing pain conditions, infection, malignancy) are excluded. |
| Secondary | Persistent opioid use | 3, 6, 9, and 12 months after surgery | Presence of persistent opioid use (binary), based on patient reporting indicating the need for daily opioid use that started after surgery or increased after surgery . |
| Secondary | Chronic postsurgical pain intensity | 3, 6, 9, and 12 months after surgery | Average intensity of chronic postsurgical pain (continuous) at rest and with movement. Pain intensity will be measured on a numeric rating scale of 0-10 where 0 is better. |
| Secondary | Satisfaction with pain control | 3, 6, 9, and 12 months after surgery | Satisfaction with pain control (continuous) will be measured using a 0 to 100 scale where a higher score is better satisfaction. |
| Secondary | Knee function | 3, 6, 9, and 12 months after surgery | Using the 12-item Oxford Knee Score (continuous) to assess knee function and pain following a total knee replacement. The score range is 0-48 where a higher score is better function. |
| Secondary | Quality of life | 3, 6, 9, and 12 months after surgery | Measured using Euro-Qol 5 dimensions scale consisting of 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This will be transformed to a utility score where 0 is death and 1 is full health (continuous). |
| Other | Adverse events | From baseline to 12 months after surgery | Operative and knee-related complications, pain medication related adverse events, readmissions, and all serious adverse events |
| Other | Health economics | From baseline to 12 months after surgery | Euro-Qol 5 dimensions scale will be used to assess health utilities for the purpose of health economic analyses (e.g., cost-effectiveness). Intervention costs and healthcare resource utilization information (e.g., hospitalization, physician visits) as well as information on productivity (e.g., time missed from work) will be collected using a self-administered questionnaire |
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
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