An interventional study of Crutch Tip Biofeedback System and Individualized FEA-Guided Postoperative Weight-Bearing in Tibial Plateau Fracture, sponsored by Comeback Mobility Inc. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Comeback Mobility Inc · Not applicable, Interventional, and Treatment
This study will compare two approaches to rehabilitation after surgery for a fracture of the upper part of the shinbone that involves the knee joint (tibial plateau fracture). The main question is whether a personalized plan for putting weight on the injured leg, combined with feedback from smart crutch tips, helps patients return to walking without assistance sooner than usual care, without increasing complications.
Participants will be assigned by chance to one of two groups:
Researchers will compare how long it takes participants to walk independently without crutches, a cane, or another walking aid. They will also assess bone healing, knee function, pain, swelling, fear of movement, adherence to weight-bearing instructions, and complications.
Participants will attend follow-up visits and complete assessments of their recovery. Imaging specialists who do not know which treatment group participants are in will assess fracture healing and whether the repaired bone has remained in position.
This multicenter, prospective, randomized controlled study will evaluate individualized postoperative weight-bearing guided by finite element analysis (FEA) and Smart Crutch Tips biofeedback following plate fixation of intra-articular proximal tibial fractures. Participants will be allocated in a 1:1 ratio to the individualized rehabilitation group or the usual-care control group.
The aim of this study is to evaluate the clinical effectiveness and safety of individualized postoperative weight-bearing prescribed using FEA combined with Smart Crutch Tips biofeedback, compared with usual care. The primary objective is to compare the time to sustained independent walking without assistive devices between the two groups. The intervention combines individualized weight-bearing prescriptions with support for adherence; therefore, the study evaluates the clinical outcomes of this combined rehabilitation approach.
In the intervention group, postoperative CT and MRI data will be used to create patient-specific biomechanical models. FEA will be used to formulate an individualized weight-bearing recommendation for the operated limb, taking into account stresses and safety factors of the fixation components, interfragmentary displacements, and mechanical conditions at the fracture site. Recommended loading will be expressed as a percentage of body weight. The treating physician will determine the final weight-bearing prescription based on the FEA recommendation and the participant's clinical condition. Smart Crutch Tips will provide biofeedback to support adherence to the prescribed regimen.
In the control group, postoperative weight-bearing will be prescribed according to usual clinical practice. Smart Crutch Tips will collect data with patient-facing loading information, step counts, and associated notifications disabled. This allows device-recorded loading data to be collected in both groups while limiting the biofeedback intervention to the individualized rehabilitation group.
Participants and treating clinicians will know the assigned group. Independent imaging assessors will be blinded to group allocation. Standardized assessments will be used to evaluate recovery of independent walking, radiographic fracture healing, maintenance of fracture reduction, knee function, symptoms, adherence, and safety.
An exploratory component will examine associations between recorded mechanical loading, fracture healing, symptoms, and complications. Data from both groups will also be used to develop and retrospectively evaluate an algorithm for weight-bearing and step-activity recommendations that does not require individual FEA when generating recommendations. This exploratory analysis will involve internal evaluation using study data.
32 studies on the registry are indexed under Tibial Plateau Fractures; 12 are open to participants now.
This study's planned enrollment of 86 is above the median of 56 across 21 interventional studies indexed under Tibial Plateau Fractures.
Browse Tibial Plateau Fractures studies →Comeback Mobility Inc is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive individualized postoperative weight-bearing recommendations based on finite element analysis (FEA) using CT and MRI obtained 4-14 days after plate fixation. At week 3 (±7 days), the treating physician prescribes loading based on FEA results, wound status, symptoms, and available imaging. The prescription is entered into Smart Crutch Tips, with patient-facing step counts, loading information, and alerts for deviations from the prescribed range enabled. The physician may adjust loading during rehabilitation based on follow-up radiographs and clinical status, including before week 16. At week 16, CT is used to assess fragment position and repeat FEA accounting for changes at the fracture site. The treating physician makes the final decision on subsequent weight-bearing.
Device: Crutch Tip Biofeedback System · Other: Individualized FEA-Guided Postoperative Weight-Bearing
Participants receive usual postoperative care, with no weight-bearing on the operated limb for 6-12 weeks after plate fixation. The treating physician determines the duration of restrictions and subsequent loading progression based on clinical status and follow-up radiographs. Smart Crutch Tips record loading and steps, but biofeedback, alerts, and patient-facing loading information and step counts are disabled. Recorded loading data are not used to provide recommendations for adjusting weight-bearing. FEA does not guide loading prescriptions in this group. Participants receive training in safe walking and device use.
Other: Usual-Care Postoperative Weight-Bearing
Smart Crutch Tips are attached to the participant's crutches or cane to record loading and steps. The system shows loading and step counts and alerts the participant when loading is outside the range prescribed by the treating physician. Participants are trained to use the system and walk safely. Device settings are updated whenever the physician changes the prescribed loading range.
Patient-specific finite element analysis (FEA) uses CT and MRI obtained 4-14 days after plate fixation to formulate a loading recommendation, considering fixation component stresses and safety factors, interfragmentary displacements, and mechanical conditions at the fracture site. At week 3 (±7 days), the treating physician prescribes loading based on the FEA recommendation and clinical findings. Loading is expressed as a percentage of body weight. The physician may adjust the prescription during rehabilitation based on clinical status and follow-up radiographs. At week 16, CT is used to assess fragment position and repeat FEA accounting for changes at the fracture site. The physician determines subsequent loading and whether restrictions can be lifted.
The treating physician prescribes no weight-bearing on the operated limb for 6-12 weeks after plate fixation. The duration of restrictions and subsequent loading progression are based on clinical status and follow-up radiographs. Smart Crutch Tips record loading and steps with biofeedback, alerts, and patient-facing loading information and step counts disabled. Recorded loading data and FEA are not used to guide weight-bearing prescriptions.
Time to Sustained Independent Walking Without Walking Aids
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.
Time frame: From plate fixation through 52 weeks
Time to Radiographic Confirmation of Complete Fracture Union
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.
Time frame: From plate fixation through 52 weeks
Proportion of Participants With Radiographic Secondary Loss of Reduction by Week 16
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
Time frame: From the first postoperative radiographic examination through the week 16 assessment after plate fixation, inclusive.
Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Scores
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.
Time frame: 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 by the Rasmussen Clinical Score
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.
Time frame: At weeks 8, 16, and 52 after plate fixation; additionally at weeks 12, 20, 26, and 39 if these conditional visits take place.
Fear of Movement Assessed by the Tampa Scale of Kinesiophobia (TSK-17)
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.
Time frame: Immediately after training at the week 3 visit (±7 days) and at week 8 after plate fixation.
Adherence to Prescribed Weight-Bearing in the Individualized Rehabilitation Group
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.
Time frame: Throughout the physician-prescribed weight-bearing restriction period, up to 52 weeks after plate fixation; summarized overall and by postoperative week.
Proportion of Participants With Fixation Failure
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.
Time frame: From informed consent through 52 weeks after plate fixation
Proportion of Participants With Confirmed Symptomatic Deep Vein Thrombosis
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.
Time frame: From informed consent through 52 weeks after plate fixation.
Proportion of Participants With Infectious Complications
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.
Time frame: From informed consent through 52 weeks after plate fixation.
Proportion of Participants Undergoing Reoperation for Fracture- or Treatment-Related Complications
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.
Time frame: From informed consent through 52 weeks after plate fixation.
Proportion of Participants With Radiographic Secondary Loss of Reduction Through Week 52
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.
Time frame: From the first postoperative radiographic examination through the week 52 assessment after plate fixation, inclusive.
Proportion of Participants With Fracture Nonunion
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.
Time frame: Through 52 weeks after plate fixation; nonunion requires at least 9 months since injury and at least 3 months without healing progression.
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Plan to share: Yes
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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