Trial · NCT07914036
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | patient satisfaction (Forgotten Joint Score-12 (FJS-12)) | 6 weeks, 3 months, 6 months, and 12 months postoperatively | Patient-reported joint awareness assessed using the 12-item Forgotten Joint Score (FJS-12). The score ranges from 0 to 100, with higher scores indicating less awareness of the operated knee during daily activities and therefore a better outcome. |
| Primary | Patient Satisfaction (2011 Knee Society Score [KSS] Satisfaction Domain) | 6 weeks, 3 months, 6 months, and 12 months postoperatively | Patient satisfaction will be assessed using the satisfaction domain of the 2011 Knee Society Score. Scores range from 0 to 40, with higher scores indicating greater patient satisfaction and therefore a better outcome. |
| Secondary | Functional outcome: (2011 Knee Society Score [KSS] Symptoms Domain) | 6 weeks, 3 months, 6 months, and 12 months postoperatively | Symptoms will be assessed using the symptoms domain of the 2011 Knee Society Score (KSS). Scores range from 0 to 25, with higher scores indicating fewer symptoms and a better outcome. |
| Secondary | Functional outcome: (2011 Knee Society Score [KSS] Functional Activity Domain) | 6 weeks, 3 months, 6 months, and 12 months postoperatively | Functional activity will be assessed using the functional activity domain of the 2011 Knee Society Score (KSS). Scores range from 0 to 100, with higher scores indicating better functional ability. |
| Secondary | Functional outcome: (2011 Knee Society Score [KSS] Expectations Domain) | 6 weeks, 3 months, 6 months, and 12 months postoperatively | Patient expectations will be assessed using the expectations domain of the 2011 Knee Society Score (KSS). Scores range from 0 to 15, with higher scores indicating greater fulfillment of patient expectations. |
| Secondary | Functional outcome: (2011 Knee Society Score [KSS] objective knee indicators domain ) | 6 weeks, 3 months, 6 months, and 12 months postoperatively | Objective knee status will be assessed using the Objective Knee Score of the 2011 Knee Society Score (KSS), which evaluates symptoms, range of motion, knee stability, and alignment. Scores range from 0 to 100, with higher scores indicating better objective knee status. |
| Secondary | Functional Outcome: (Oxford Knee Score [OKS]) | 6 weeks, 3 months, 6 months, and 12 months postoperatively | Functional outcome will be assessed using the Oxford Knee Score (OKS), a 12-item patient-reported measure evaluating knee pain and function. Scores range from 0 to 48, with higher scores indicating better knee function and less pain. |
| Secondary | Radiological accuracy: Hip-Knee-Ankle angle (HKA) | 6 weeks postoperatively | Coronal lower-limb alignment will be assessed on standing full-length lower-limb radiographs using the hip-knee-ankle (HKA) angle, measured in degrees. The HKA angle will be determined from the mechanical axes of the femur and tibia. Deviation from the prespecified alignment target will also be recorded. An alignment outlier will be defined according to the prespecified study threshold, including deviation greater than 3 degrees from the intended alignment target where applicable. |
| Secondary | Radiological accuracy: Knee Society Radiographic Evaluation System (KSRES) | immediate postoperative , 6 months and and 12 months postoperatively | Postoperative radiographs will be obtained (Xray knees Ap, lateral and if applicable; merchant view) and will be assessed using the Knee Society Radiographic Evaluation System, which provides a standardized assessment of total knee arthroplasty component alignment and fixation. Radiolucent lines and osteolysis will be recorded according to predefined femoral and tibial component zones, and component position will be assessed in the coronal and sagittal planes. |
| Secondary | Femoral Component Rotational Alignment | immediate postoperative | Femoral component rotational alignment will be assessed using postoperative computed tomography (CT). Rotation will be measured in degrees relative to the predefined femoral anatomical reference axis. The magnitude and direction of rotational deviation will be recorded. |
| Secondary | Tibial component rotational alignment | immediate postoperative | Tibial component rotational alignment will be assessed using postoperative computed tomography (CT). Rotation will be measured in degrees relative to the predefined tibial anatomical reference axis. The magnitude and direction of rotational deviation will be recorded. |
| Secondary | Patellar Height | Immediate postoperative period, 6 months, and 12 months postoperatively | Patellar height will be assessed on standardized lateral knee radiographs using the Caton-Deschamps Index (CDI). The index is calculated as the ratio between the distance from the inferior edge of the patellar articular surface to the anterosuperior angle of the tibial plateau and the length of the patellar articular surface. Higher values indicate a relatively higher patellar position. |
| Secondary | Operative Time (minutes) | Intraoperative | Total operative time will be recorded in minutes from skin incision to completion of skin closure. |
| Secondary | perioperative Blood Loss | From the start of surgery until drain removal, typically within 24-48 hours postoperatively | Measured perioperative blood loss will be calculated as the sum of estimated intraoperative blood loss (calculated from suction canister volume after subtraction of irrigation fluid plus gravimetric assessment of blood absorbed by surgical swabs and sponges.) and cumulative postoperative closed-suction drain output, expressed in milliliters. |
| Secondary | Requirement for Soft-Tissue Release | Intraoperative | The number and proportion of participants requiring one or more soft-tissue releases during total knee arthroplasty to achieve satisfactory ligament balance will be recorded. and also , the specific soft-tissue structure or structures released to achieve ligament balance will be recorded. These may include the medial collateral ligament, posteromedial capsule, posterior capsule, iliotibial band, lateral collateral ligament, popliteus tendon, or other periarticular soft-tissue structures as clinically indicated. |
| Secondary | Final Polyethylene Insert Thickness | Intraoperative | The thickness of the final implanted polyethylene tibial insert will be recorded in millimeters. |
| Secondary | intraoperative and postoperative Blood transfusion (Packed RBCS units) | From the start of surgery through hospital discharge | The number and proportion of participants receiving packed red blood cell transfusion during the intraoperative or postoperative period will be recorded. |
| Secondary | Length of Hospital Stay ( days) | From surgery through hospital discharge | Duration of postoperative hospitalization will be measured in days from the date of surgery until hospital discharge. |
| Secondary | Incidence of infection | through study completion, an average of 1 year follow up | ( prosthetic joint infection ) PJI will be diagnosed according to the 2018 evidence-based International Consensus Meeting (ICM) criteria, based on the presence of a major criterion or fulfillment of the validated weighted minor-criteria scoring system. |
| Secondary | periprosthetic fractures | From the perioperative period through study completion, up to atleast 12 months postoperatively |
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/NCT07914036/registered