Trial · NCT04167163
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs) | Baseline and approximately 18 months on study (15 months post-TKA) | Bone mineral density change at the 25% ROI of the surgical leg. Dual-energy X-ray absorptiometry (DXA) measured BMD was obtained at a point (ROI) 25% the length of the total surgical femur. Percent change at 25% ROI was calculated from baseline to 18 months. |
| Secondary | Change in Distal Femoral BMD at the 15% and 60% ROI | Baseline and approximately 18 months on study (15 months post-TKA) | Bone mineral density percent change at the 15% and 60% ROI of the surgical leg |
| Secondary | TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs | 18 months on study (15 months post-TKA) | Trabecular bone score (TBS) assessment by Texture Research Investigation (Platform (TRIP) software change at the 15% and 25% femur ROIs (TBS \>1.350 is normal; TBS between 1.200 and 1.350 is indicative of partially degraded microarchitecture; and TBS \<1.200 equals degraded microarchitecture). |
| Secondary | Knee Injury & Osteoarthritis Outcome Score (KOOS) JR | 18 months on study (15 months post-TKA) | Patient reported knee function score. The KOOS, JR was developed from the original long version of the Knee injury and Osteoarthritis Outcome Score (KOOS) survey using Rasch analysis. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score (0-100). The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. |
| Secondary | Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Physical Health Component | Baseline and approximately 18 months on study (15 months post-TKA) | 12 Item Health Survey using patient's self assessment of their perspective of their health and ability to do daily functions. Scores are derived using an algorithm that is referenced to a metric centered at 50.0 where a zero score indicates the lowest level of health and 100 indicates the highest level of health. |
| Secondary | Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Mental Health Component | Baseline and approximately 18 months on study (15 months post-TKA) | 12 Item Health Survey using patient's self assessment of their perspective of their health and ability to do daily functions. Scores are derived using an algorithm that is referenced to a metric centered at 50.0 where a zero score indicates the lowest level of health and 100 indicates the highest level of health. |
| Secondary | Forgotten Joint Survey(FJS) Score | 18 months on study (15 months post-TKA) | FJS-12 consists of 12 questions and is scored using a 5-point response format with the raw scores transformed onto a 0- to 100-point scale. High scores indicate good outcome, that is, a high degree of forgetting the joint in everyday life (forgotten joint phenomenon). |
| Secondary | Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass | Baseline and approximately 18 months on study (15 months post-TKA) | Change in total body composition using bioelectrical impedance analysis of lean mass. |
| Secondary | Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass. | Baseline and approximately 18 months on study (15 months post-TKA) | Change in total body composition using bioelectrical impedance analysis of fat mass. |
| Secondary | TKA Complications: Number of Participants Needed Revision Surgery | 18 months on study (15 months post-TKA) | TKA complications: Number of participants needed revision surgery |
| Secondary | TKA Complications: Number of Participants Had Fracture | 18 months on study (15 months post-TKA) | TKA complications: Number of participants had fracture |
| Secondary | Precision Error on Knee Bone Density Measurement | 18 months on study (15 months post-TKA) | Precision assessment in the field of bone densitometry is the process whereby the ability of the instrument and the technologist to reproduce similar results, given no real biologic change, is tested. To achieve statistical power, the investigators will take duplicate knee bone density measurements on 30 participants at either their 6 month or 15 month visit. The standard deviation for each participant is calculated, then the root mean square standard deviation for the group is calculated. The mathematical result of precision assessment is displayed as percent coefficient of variation (CV). |
| Other | Change in Femur Cortical Thickness at the 15%, 25% and 60% Femur ROIs | Baseline and approximately 18 months on study (15 months post-TKA) | Cortical thickness change at the 15% and 60% ROI of the surgical leg |
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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GET https://conductscience.org/api/trials/v1/NCT04167163/registered