Help patients adhere to weight-bearing protocols to enhance bone healing & prevent fixation failure. These protocols reduce complications that lead to reoperations, generating additional revenue for practices and savings for payers.
Help patients adhere weight-bearing protocols to enhance bone healing & prevent fixation failure. These protocols reduce complications that lead to reoperations, generating additional revenue for practices and savings for payers.
Calculate safe
weight-bearing with
post-op CT-based FEA*
*FEA – Finite Element Analysis
Prescribe patient-specific weight-bearing protocol
Patients follow their protocol using the biofeedback device
PT** monitors protocol compliance and bills for RTM***
**PT – Physical Therapist
***RTM – Remote Therapeutic Monitoring
Calculate safe
weight-bearing with
post-op CT-based FEA*
*FEA – Finite Element Analysis
Prescribe patient-specific weight-bearing protocol
Patients follow their protocol using the biofeedback device
PT** monitors protocol compliance and bills for RTM***
**PT – Physical Therapist
***RTM – Remote Therapeutic Monitoring
ComeBack Mobility provides personalized post-operative rehabilitation protocols for lower-limb injuries, delivered through Smart Crutch Tips™ – an FDA-cleared device that helps patients accurately follow prescribed weight-bearing and step targets. These protocols are generated from CT-based finite-element analysis, allowing for the tailoring of loading and activity levels to achieve optimal interfragmentary motion, appropriate strain at the fracture site, and fixation safety throughout healing.
Traditional rehabilitation lacks individualized biomechanical guidance. Surgeons rely on subjective judgments of fixation stability and often prescribe 6–12 weeks of no weight-bearing, which can lead either to excessive loading later causing implant failure or fracture displacement, or to prolonged immobilization, increasing the risks of deep vein thrombosis and muscular atrophy.
By enabling safe, earlier mobilization, we reduce complications that prolong recovery and drive costs. Hospitals benefit through shorter lengths of stay and fewer readmissions. For payers, preventing these events lowers the need for costly revision surgeries and reduces long-term disability expenses. Faster recovery helps patients return to work sooner, improving both clinical and economic outcomes.
in their rehabilitation
axial load
step data
of pain and swelling
Weight-bearing as tolerated is not always safe!
Individualized Determination of the Mechanical Fracture Environment After Tibial Exchange Nailing—A Simulation-Based Feasibility Study
Benedikt J. Braun, Marcel Orth, Stefan Diebels, Kerstin Wickert, Annchristin Andres, Joshua Gawlitza, Arno Bücker, Tim Pohlemann, Michael Roland (2021)
Weight-bearing as tolerated is not always safe!
Case:
A 55-year-old woman broke a leg, 7 weeks after surgery, the metal piece used to fix her bone broke, and her leg broke again
Why It Happen?
Researchers found that too much load during walking caused the implant to fail
Applying Right Amount Of Strain Improves Healing!
If strain goes beyond certain limits – it slows down the healing process!
Controlled Mechanical Stimulation in the Treatment of Tibial Fractures
John Kenwright, Ph.D., F.R.C.S., And Allen E. Goodship,H.D., D.V.Sc., M.R.C.V.S., (1988)
Applying Right Amount Of Strain Improves Healing!
If strain goes beyond certain limits – it slows down the healing process!
Magnitudes of local stress & strain along bony surfaces
Predict the course & type of fracture healing!
Magnitudes of local stress and strain along bony surfaces predict the course and type of fracture healing
L.E. Claes, C.A. Heigele, (1999)
Magnitudes of local stress & strain along bony surfaces
Predict the course & type of fracture healing!
Dependence of healing on mechanical conditions:
Strain <5% & pressure <0.15 MPa → intramembranous bone formation.
Pressure ≈0.15 MPa → endochondral ossification.
High strain and pressure → fibrous tissue or cartilage.
Optimal interfragmentary mobility:
Initial mobility of ~1.2 mm stimulates callus formation. (IFM)
Gradual reduction of IFM due to increasing callus stiffness.
Reverse Dynamisation Boosts Healing by Controlling Strain
Reverse Dynamisation: A Modern Perspective On Stephan Perren’s Strain Theory
V. Glatt, C.H. Evans and K. Tetsworth, (2021)
Reverse Dynamisation Boosts Healing by Controlling Strain
Early Fracture Activity is Crucial for Bone Regeneration
The relation between fracture activity and bone healing with special reference to the early healing phase – A preclinical study
Markus Windolf, Manuela Ernst, Ronald Schwyn, Daniel Arens, Stephan Zeiter, (2021)
Early Fracture Activity is Crucial for Bone Regeneration
Validation Testing of a New Crutch Tip Biofeedback Device for Prescribed Lower Extremity Weight-Bearing
Kevin E. Brueilly, Amanda M. Feller, Jonathan M. Ahearn, Jonathan S. Goodwin (January 2024.)
The ComeBack Mobility crutch tip system could be useful and should be considered for clinical use as a reliable and valid tool in providing auditory feedback for compliance to a prescribed weight-bearing protocol.
ComeBack Mobility Crutch Tip System
Improves patients weight-bearing compliance and satisfaction!
Smart Crutch Tips Enhance Weight-Bearing Adherence and Usability in Home-Based Rehabilitation (July 2025)
ComeBack Mobility Crutch Tip System
Improves patients weight-bearing compliance and satisfaction!
Weight-bearing compliance:
73.60% in Intervention group vs. 21.10% in Control group.
Usability:
SUS score of 84.25 – “Excellent Usability.” Patient Satisfaction: 10/10 likelihood to recommend the device.
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
Validation Testing of a New Crutch Tip Biofeedback Device for Prescribed Lower Extremity Weight-Bearing
Brueilly et al.
“Smart Crutch” Real Time Feedback Aids in Partial Weight-Bearing Adherence Following Lower Extremity Fracture: A Pilot Study
Kenneth A. Egol, MD et al.
Optimizing Tibial Fracture Healing with Prescribed Early Weight Bearing and Real-Time Feedback: A Case Report
Glatt et al.
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft
Fractures ClinicalTrials.gov ID NCT07092579
Glatt et al.
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures ClinicalTrials.gov ID NCT07134257
Glatt et al.
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures ClinicalTrials.gov ID NCT07138066
Glatt et al.
Controlled Mechanical Stimulation in the Treatment of Tibial Fractures
Kenwright et al.
The relation between fracture activity and bone healing with special reference to the early healing phase – A preclinical study
Windolf et al.
Reverse Dynamisation: A Modern Perspective On Stephan Perren’s Strain Theory
Glatt et al.
Magnitudes of local stress and strain along bony surfaces predict the course and type of fracture healing
Kenwright et al.
Individualized Determination of the Mechanical Fracture Environment After Tibial Exchange Nailing—A Simulation-Based Feasibility Study
Benedikt et al.
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Reoperation | 25,0% | Lundin N. et al. (2022) Eur J Orthop Surg Traumatol.
Complications after surgical treatment of pelvic fractures: a five-year follow-up of 194 patients |
| Non-union | 3,5% | Yong-Cheol Y. et al. (2023) Eur J Orthop Surg Traumatol.
Risk factors for pubic ramus fracture nonunion after conservative treatment of pelvic ring injuries: a retrospective cohort multicenter study |
| Depression | 6,6% | Ali K.A. et al. (2024) BMC Geriatr.
Sleep quality and psychological health in patients with pelvic and acetabulum fractures: a cross-sectional study |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Non-union — Talus | 8% | Wijers O. et al. (2022) Foot Ankle Orthop.
Complications and Functional Outcome Following Operative Treatment of Talus Neck and Body Fractures: A Systematic Review |
| Non-union — Navicular | 20% | Shakked R.J. (2017) et al. Curr Rev Musculoskelet Med.
Tarsal navicular stress fractures |
| Non-union — Jones fracture | 7.2% | Kavanagh A.M. (2025) J Foot Ankle Surg.
Rate of bony union after Jones fracture fixation in the general population |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Hip re-revisions | 15,80% | Badarudeen S. et al. (2017) J Arthroplasty.
Complications After Revision Total Hip Arthroplasty in the Medicare Population |
| Infection | 17,30% | Badarudeen S. et al. (2017) J Arthroplasty.
Complications After Revision Total Hip Arthroplasty in the Medicare Population |
| Dislocation | 5,43% | Badarudeen S. et al. (2017) J Arthroplasty.
Complications After Revision Total Hip Arthroplasty in the Medicare Population |
| Venous thromboembolic disease (VTE) | 11,10% | Badarudeen S. et al. (2017) J Arthroplasty.
Complications After Revision Total Hip Arthroplasty in the Medicare Population |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Knee re-revisions | 14,30% | Geary M.B. et al. (2020) J Arthroplasty.
Why Do Revision Total Knee Arthroplasties Fail? A Single-Center Review of 1632 Revision Total Knees Comparing Historic and Modern Cohorts |
| Aseptic loosening | 5,31% | Geary M.B. et al. (2020) J Arthroplasty.
Why Do Revision Total Knee Arthroplasties Fail? A Single-Center Review of 1632 Revision Total Knees Comparing Historic and Modern Cohorts |
| Instability | 2,67% | Geary M.B. et al. (2020) J Arthroplasty.
Why Do Revision Total Knee Arthroplasties Fail? A Single-Center Review of 1632 Revision Total Knees Comparing Historic and Modern Cohorts |
| Infection | 17,70% | Geary M.B. et al. (2020) J Arthroplasty.
Why Do Revision Total Knee Arthroplasties Fail? A Single-Center Review of 1632 Revision Total Knees Comparing Historic and Modern Cohorts |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Re-tear | 19.1% | Schweizer C. et al. (2021) Knee Surg Sports Traumatol Arthrosc.
Nineteen percent of meniscus repairs are being revised and failures frequently occur after the second postoperative year: a systematic review and meta-analysis with a minimum follow-up of 5 years |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Re-rupture | 9.3% | Della Villa F. et al. (2023) Br. J. Sports Med.
High rate of second ACL injury following ACL reconstruction in male professional footballers: an updated longitudinal analysis from 118 players in the UEFA Elite Club Injury Study |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Re-rupture | 8.6% | Grassi A. et al. (2025) Knee Surg Sports Traumatol Arthrosc.
A systematic review of distal medial collateral ligament Stener-like lesion: Good clinical and functional outcomes of surgical treatment |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Graft failure + Graft detachment | 16.6% | Bauer S. et al. (2011) Knee.
Knee joint preservation with combined neutralising High Tibial Osteotomy (HTO) and Matrix-induced Autologous Chondrocyte Implantation (MACI) in younger patients with medial knee osteoarthritis: A case series with prospective clinical and MRI follow-up over 5 years |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Graft failure + Graft detachment | 16.6% | Bauer S. et al. (2011) Knee.
Knee joint preservation with combined neutralising High Tibial Osteotomy (HTO) and Matrix-induced Autologous Chondrocyte Implantation (MACI) in younger patients with medial knee osteoarthritis: A case series with prospective clinical and MRI follow-up over 5 years |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Graft failure + Graft detachment | 16.6% | Bauer S. et al. (2011) Knee.
Knee joint preservation with combined neutralising High Tibial Osteotomy (HTO) and Matrix-induced Autologous Chondrocyte Implantation (MACI) in younger patients with medial knee osteoarthritis: A case series with prospective clinical and MRI follow-up over 5 years |
| Weight-Bearing Related Complication Rate | Peer-reviewed scientific literature | |
|---|---|---|
| Re-rupture | 5.6% | Stewart A.B.et al. (2021) Arthrosc Tech.
Mini-Open Achilles Repair With a Flat Braided Suture in a Low-Profile Configuration |
| Tear pattern | |||||
| Longitudinal-vertical (bucket handle tear) | Horizontal | Radial | Vertical flap | Horizontal flap | Complex |
| Tear depth | |||||
| Partial/ complete | |||||
| Radial location | |||||
| Posterior/Mid body/Anterior | |||||
| Location – width | |||||
| Zone 1 – Red-Red / Zone 2 – White-Red / Zone 3 – White-White | |||||
| Quality of tissue | |||||
| Non-degenerative / Degenerative / Undetermined | |||||
ACL/PCL
| ||||
MCL/LCL |
Type 1 / Type 2 / Type 3 / Type 4
| Internal fixation | External fixation |
| Precise / Fitbone / ISKD | Ilizarov / TSF (Taylor Spatial Frame) / Monolateral Fixator |
| Total / Partial |
| Revision / Re-revision |
| Total / Partial |
| Revision / Re-revision |
With Smart Crutch Tips, your doctor can monitor the course of rehabilitation and help you avoid complications
a) loosening of osseous retainer screws
b) migration of screws or spokes
c) loosening of intramedullary retainer locking screws
d) loosening of the intramedullary shaft
e) loosening of the blade of the osseous plate or blocked epiphyseal screws (LCP, DHS, DCS systems)
f) teething of wire seam
a) deformation of the plate
b) deformation of the intramedullary shaft
c) deformation of the locking screws of the intramedullary retainer
a) loosening or teething of spokes or transosseous rods of an external fixer
b) fracture of spokes or transosseous rods of an external fixator
c) destabilization or damage to the external structure of the AVF
a) transplant migration
b) transplant fracture
c) fixation migration after consolidation is completed
a) vein thrombosis of the lower extremities
b) thromboembolic complications
c) muscle and joint contractures
d) muscle weakness and muscle volume reduction
e) gait stereotype disturbances
a) fixation plates and screws break muscle weakness
b) Dislocation of prosthesis joint contractures
c) Bone density loss gait disturbances
d) Blood clots
e) Muscle atrophy
Chief of Trauma, NYU Langone Orthopedics
“Patients receiving real-time feedback demonstrated more than a three-fold improvement in adherence to prescribed partial weight-bearing”
Director of Research, UT Health San Antonio
“Replacing the standard “weight-bearing as tolerated” approach with personalized, monitored early loading significantly accelerates bone healing.”
CSU Prof. & Assoc. Director Physical Therapy
“It gives everybody an opportunity to just have some more feedback”
Maastricht University Medical Center, the Netherlands. Does research in Surgery and Traumatology. Current project – ‘Permissive weight bearing’
“With the feedback patients gets from the Crutches, they will back to walk 8 weeks sooner”
Doctor of Physical Therapy, Regional Director
Moriarty Physical Therapy
“The biggest issue for me is that people aren’t listening, so it’s an issue of not enough pressure or too much pressure. With teenagers it’s a little bit less of «too much», it’s a matter of putting enough weight to it, so I can track it. I can see their percent, so when they come I can say: «Hey, you are not doing enough. You’ve make a thousand steps the first week and week 2 you kinda fall off. You have to stop your game up and get more compliance to put more pressure or ask them not to put too much pressure”
PT, DPT, CSCS, USAW, SFMA, TPI, Clinical Director Professional Care Physical Therapy
“The issue arise is that one the patient foot is out of the scale, really there is no other way to tell how much weight they are actually putting. There is no objective medical founded”
With Smart Crutch Tips, your doctor can monitor the course of rehabilitation and help you avoid complications
a) loosening of osseous retainer screws
b) migration of screws or spokes
c) loosening of intramedullary retainer locking screws
d) loosening of the intramedullary shaft
e) loosening of the blade of the osseous plate or blocked epiphyseal screws (LCP, DHS, DCS systems)
f) teething of wire seam
a) deformation of the plate
b) deformation of the intramedullary shaft
c) deformation of the locking screws of the intramedullary retainer
a) loosening or teething of spokes or transosseous rods of an external fixer
b) fracture of spokes or transosseous rods of an external fixator
c) destabilization or damage to the external structure of the AVF
a) fixation plates and screws break muscle weakness
b) Dislocation of prosthesis joint contractures
c) Bone density loss gait disturbances
d) Blood clots
e) Muscle atrophy
a) transplant migration
b) transplant fracture
c) fixation migration after consolidation is completed
a) vein thrombosis of the lower extremities
b) thromboembolic complications
c) muscle and joint contractures
d) muscle weakness and muscle volume reduction
e) gait stereotype disturbances
Regarding the physicians using our product, we have been working with orthopedic surgeons and rehabilitation specialists in several leading healthcare institutions.
The idea of attaching Smart Tips to crutches was tested with real patients, and unlike insoles, Smart Crutch Tips are:
– Always with the patient, even at night, when the patient is barefoot
– More durable – 3 years of use
– Available to consumers of any age and shoe size
– More affordable to implement
– Fit the reusable model
When walking on crutches, there is a moment during which the healthy leg is completed lifted off the ground and the entire load is distributed between the crutches and the injured leg.
We can determine how much load is placed on the injured limb by subtracting the amount of weight on the crutches from the patient’s body weight. For example: if a patient’s weight is 80 kg and during a step he transferred 60 kg to crutches, then 20kg of pressure was exerted on the injured limb.
The accuracy of Smart Crutch Tips is 98,5%.
The amount of initial weight bearing can be set from 0% NWB to 50% PWB. The upper threshold for graduated WBAT is 80%.
The Smart Crutch Tips device can be used by patients recovering from nonsurgical and surgical treatments for hip, thigh, knee, shin, ankle, and foot injuries and pathologies
Yes, Canes with diameters from 17 to 30mm. A patients can begin their gait rehabilitation on crutches and switch to a cane for quality gait progression.
No, it doesn’t need FDA approval. It’s Medical Device class II, 501 (k) Exempt. It’s FDA registered and has all necessary regulatory approvals for official sales in the US market.
Yes, it’s covered by insurance. The device usage itself doesn’t cover due to new technology on the market. However, the doctors work is covered. So they can get additional money for device setup and biofeedback patient training and Remote Patient Monitoring (RPM).
– Yes. We change the devices if anything happens during patient usage.
– Warranty for hospitals – 1 year.
– However, we can provide an expanded warranty for hospitals for up to 3 years.
Yes, it has protection from dust and water – IP 54. It can be used while rain or snow and operates in temperatures: from 5F to 86F.
Weight-bearing tracking service to control the load on the injured leg during rehabilitation
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For inquiries regarding collaboration on
clinical study in Ukraine, contact us at:
+380-(98)-336-37-03
help@comebackmobility.com
