Trial · NCT07897149
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 | Time to Sustained Independent Walking Without Walking Aids | From plate fixation through 52 weeks | Time in days from plate fixation to the first day of walking without crutches, a cane, or another walking aid, with pain in the injured limb during walking of no more than 2 on a 0-10 visual analogue scale at the time of transition, and no return to walking aids for at least 7 consecutive days. The event date is the first day of the confirmed period, not the date of confirmation. An independent assessor blinded to treatment group allocation confirms that the criteria are met and verifies the event date using participant reports and supporting records. Device non-use alone does not establish the outcome. |
| Secondary | Time to Radiographic Confirmation of Complete Fracture Union | From plate fixation through 52 weeks | Time in days from plate fixation to the first radiographic examination confirming complete fracture union. Complete union is defined as disappearance of the fracture line due to filling with bone tissue and complete bone remodeling at the fracture site. Anteroposterior, lateral, and oblique radiographs are compared with previous images and assessed by two independent radiologists blinded to treatment group allocation. Disagreements are resolved by a third blinded radiologist. Partial union does not meet the endpoint. The event date is the date of the first examination confirming complete union. |
| Secondary | Proportion of Participants With Radiographic Secondary Loss of Reduction by Week 16 | From the first postoperative radiographic examination through the week 16 assessment after plate fixation, inclusive. | Proportion of participants with secondary loss of reduction on radiographs compared with the first postoperative radiographic examination. Loss of reduction is defined as at least one of the following changes: an increase in articular surface depression of at least 2 mm; an increase in interfragmentary gap of at least 2 mm; an increase in tibial plateau width of at least 5 mm; or worsening of varus/valgus alignment or posterior tibial slope by at least 5 degrees. These thresholds refer to changes from the postoperative baseline, not absolute residual displacement. Radiographs are assessed independently by radiologists blinded to treatment group allocation. Each participant is counted once, regardless of the number of criteria met. Insufficient imaging without a confirmed positive finding is classified as indeterminate, not as absence of loss of reduction |
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Scores | At weeks 8, 16, and 52 after plate fixation; additionally at weeks 12, 20, 26, and 39 if these conditional visits take place. | Patient-reported knee outcomes assessed using the five KOOS subscales: Pain, Other Symptoms, Activities of Daily Living, Sport and Recreation Function, and Knee-Related Quality of Life. Each subscale is scored separately from 0 to 100, with higher scores indicating fewer knee problems. No overall total score is calculated. Assessments are performed at all attended in-person follow-up visits. Weeks 8, 16, and 52 are the mandatory time points for comparison between groups. Assessments at conditional visits are analyzed accounting for cancellation of these visits after confirmed fracture union. |
| Secondary | Knee Function Assessed by the Rasmussen Clinical Score | At weeks 8, 16, and 52 after plate fixation; additionally at weeks 12, 20, 26, and 39 if these conditional visits take place. | Knee function assessed using the Rasmussen Clinical Score, covering pain, walking capacity, knee extension, range of motion, and knee stability. Higher scores indicate better knee function. Range of motion is measured with a goniometer. Weight-bearing tests are performed only when clinically safe. Assessments are conducted at all attended in-person follow-up visits, with weeks 8, 16, and 52 serving as the mandatory time points for comparison between groups. |
| Secondary | Fear of Movement Assessed by the Tampa Scale of Kinesiophobia (TSK-17) | Immediately after training at the week 3 visit (±7 days) and at week 8 after plate fixation. | Fear of movement assessed using the 17-item Tampa Scale of Kinesiophobia (TSK-17). Total scores range from 17 to 68, with higher scores indicating greater fear of movement or reinjury. The first assessment is conducted remotely immediately after participant training at the week 3 visit, and the assessment is repeated at week 8. The first assessment is a post-training measurement and is not considered a pre-intervention baseline. |
| Secondary | Adherence to Prescribed Weight-Bearing in the Individualized Rehabilitation Group | Throughout the physician-prescribed weight-bearing restriction period, up to 52 weeks after plate fixation; summarized overall and by postoperative week. | Percentage of technically valid recorded steps within the prescribed loading range in the individualized rehabilitation group. The analytical range is the prescribed target ±10 percentage points of body weight, with a lower limit of zero. Each step is compared with the prescription active at the time of recording. Only days with at least 20 technically valid steps and a known prescription are included. Adherence is calculated as 100 × valid steps within range / all valid steps on eligible days. It is summarized over the entire restriction period and separately by postoperative week. Higher percentages indicate greater adherence. Days with insufficient data are excluded, not assigned 0% or 100%. Participants without eligible data are classified as not evaluable. This outcome is not calculated in the usual-care group. |
| Secondary | Proportion of Participants With Fixation Failure | From informed consent through 52 weeks after plate fixation | Proportion of participants with implant breakage or deformation, or implant migration or loosening associated with loss of stability. Events are documented using available imaging and clinical assessments. The date, type of failure, diagnostic findings, and treatment are recorded. Fixation failure is assessed separately from secondary loss of fracture reduction. Each participant with at least one qualifying event is counted once, regardless of the number of fixation failure events. |
| Secondary | Proportion of Participants With Confirmed Symptomatic Deep Vein Thrombosis | From informed consent through 52 weeks after plate fixation. | Proportion of participants with symptomatic deep vein thrombosis confirmed by diagnostic imaging or another appropriate instrumental examination. Routine ultrasound screening for asymptomatic thrombosis is not performed. The date, diagnostic findings, and treatment of each confirmed event are recorded. Each participant with at least one confirmed symptomatic event is counted once, regardless of the number of events. |
| Secondary | Proportion of Participants With Infectious Complications | From informed consent through 52 weeks after plate fixation. | Proportion of participants with at least one infectious complication related to the study fracture or its treatment, including deep infection. The date, infection site, diagnostic findings, and treatment are recorded. Each participant with at least one qualifying infection is counted once, regardless of the number of infectious events. |
| Secondary | Proportion of Participants Undergoing Reoperation for Fracture- or Treatment-Related Complications | From informed consent through 52 weeks after plate fixation. | Proportion of participants undergoing at least one additional operation because of a complication of the study fracture or its treatment. Implant removal or replacement due to a complication is included, even if the procedure was scheduled in advance. Routine implant removal without complications and operations for unrelated diseases or injuries are excluded. The date and indication for each qualifying operation are recorded. Each participant is counted once, regardless of the number of qualifying reoperations. |
| Other | Proportion of Participants With Radiographic Secondary Loss of Reduction Through Week 52 | From the first postoperative radiographic examination through the week 52 assessment after plate fixation, inclusive. | Proportion of participants with any confirmed secondary loss of reduction on follow-up radiographs compared with the first postoperative radiographic examination. Loss of reduction is defined as at least one of the following changes: increased articular surface depression of at least 2 mm; increased interfragmentary gap of at least 2 mm; increased tibial plateau width of at least 5 mm; or worsening varus/valgus alignment or posterior tibial slope by at least 5 degrees. These thresholds refer to changes from the postoperative baseline, not absolute residual displacement. Each participant is counted once, regardless of the number of criteria met. Corrective surgery does not negate a previously confirmed event. Radiographic findings are assessed separately from CT findings. Insufficient imaging without a confirmed positive finding is classified as indeterminate. |
| Other | Proportion of Participants With Fracture Nonunion | Through 52 weeks after plate fixation; nonunion requires at least 9 months since injury and at least 3 months without healing progression. | Proportion of participants with incomplete fracture union at least 9 months after injury and no evidence of healing progression for at least 3 months. Serial images are compared to assess healing progression. The date of diagnosis is the actual date of the assessment establishing that the criteria are met, not automatically the date of the week 52 visit. Earlier clinical diagnoses of nonunion or operations performed for nonunion are documented separately and do not automatically satisfy this outcome definition. If serial imaging is insufficient to assess healing progression, that component is classified as indeterminate. Each participant meeting the criteria is counted once. |
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/NCT07897149/registered