Biofeedback weight-bearing devices & individual weight-bearing protocols

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.

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How Smart Crutch Tip Devices Work

1. *CBM create 3D model from a post-op CT scan & calculate what load help the bone heal without compromising fixation

2. via *CBM app prescribe personalized load for the patient & remotely monitors compliance

3. Patient use *CBM app & FDA cleared Crutch Tips to follow the prescribed loading plan.

How it Works

Get Prices & Technical Characteristics

Get Prices & Technical Characteristics

Clinical Research

proved significant patient outcomes using a weight-bearing tracking
biofeedback device
Article
Clinical evidence

Weight-bearing as tolerated is not always safe!

Article

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)

Clinical evidence

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!

Article

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)

Clinical evidence

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!

Article

Magnitudes of local stress and strain along bony surfaces predict the course and type of fracture healing

L.E. Claes, C.A. Heigele, (1999)

Clinical evidence

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

Article

Reverse Dynamisation: A Modern Perspective On Stephan Perren’s Strain Theory

V. Glatt, C.H. Evans and K. Tetsworth, (2021)

Clinical evidence

Reverse Dynamisation Boosts Healing by Controlling Strain

  • Initial flexible fixation promotes callus formation through controlled micromotion;
  • Followed by stiff fixation to support bone consolidation;
  • Proven in animal and pilot clinical studies to reduce healing time by ~50%;
  • Supports Perren’s strain theory: 2–10% strain → optimal endochondral healing.

Early Fracture Activity is Crucial for Bone Regeneration

Article

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)

Clinical evidence

Early Fracture Activity is Crucial for Bone Regeneration

  • First 3 weeks = key window for healing
  • More early step cycles = stronger bone
  • High activity → larger callus & higher torsional strength
  • Early weight-bearing correlates with faster regeneration
Article

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.)

Clinical evidence

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!

Article

Smart Crutch Tips Enhance Weight-Bearing Adherence and Usability in Home-Based Rehabilitation (July 2025)

Clinical evidence

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.

In Progress
Article

Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures

Clinical evidence
In Progress
In Progress
Article

Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures

Clinical evidence
In Progress
In Progress
Article

Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures

Clinical evidence
In Progress

ICD-10 Diagnoses Requiring WB

Endoprosthetics
 
  • S32.4 – Fracture of acetabulum
  • S72.0 – Fracture of head and neck of femur
  • S72.1 – Pertrochanteric fracture
  • M16.0 – Bilateral primary osteoarthritis of hip
  • M16.1 – Unilateral primary osteoarthritis of hip
  • M16.2 – Bilateral osteoarthritis resulting from hip dysplasia
  • M16.3 – Unilateral osteoarthritis resulting from hip dysplasia
  • M16.9 – Osteoarthritis of hip, unspecified
  • M24.7 – Protrusio acetabuli
  • M45 – Ankylosing spondylitis
  • М069 – Rheumatoid arthritis, unspecified
  • М870 – Idiopathic aseptic necrosis of bone
 
Osteosynthesis
 
  • S32.4 – Fracture of acetabulum
  • S72.7 – Subtrochanteric fracture of femur
  • S72.8 – Other fracture of femur
  • S72.9 – Unspecified fracture of femur
  • S72.1 – Pertrochanteric fracture
  • Corrective osteotomy
 
Injury
 
  • S32.4 – Fracture of acetabulum
  • S70.0 – Contusion of hip
  • S72.8 – Other fracture of femur
  • S72.9 – Unspecified fracture of femur
  • S73.0 – Subluxation and dislocation of hip
  • S73.1 – Sprain of hip
 
Diseases
 
  • M16.0 – Bilateral primary osteoarthritis of hip
  • M16.1 – Unilateral primary osteoarthritis of hip
  • M16.2 – Bilateral osteoarthritis resulting from hip dysplasia
  • M16.3 – Unilateral osteoarthritis resulting from hip dysplasia
  • М16.4 – Bilateral post-traumatic osteoarthritis of hip
  • М16.5 – Unilateral post-traumatic osteoarthritis of hip
  • M16.9 – Osteoarthritis of hip, unspecified
  • M19.9 – Osteoarthritis, unspecified site
 
Osteosynthesis
 
  • S72.1 – Pertrochanteric fracture
  • S72.2 – Subtrochanteric fracture of femur
  • S72.3 – Fracture of shaft of femur
  • S72.4 – Fracture of lower end of femur
 
Injury
 
  • S72.1 – Pertrochanteric fracture
  • S72.2 – Subtrochanteric fracture of femur
  • S72.3 – Fracture of shaft of femur
  • S72.4 – Fracture of lower end of femur
 
Diseases
 
  • M16.9 -Osteoarthritis of hip, unspecified
  • M87.0 – Idiopathic aseptic necrosis of bone
  • M93.9 – Osteochondropathy, unspecified
Osteosynthesis
 
  • S92.0 – Fracture of calcaneus
  • S92.1 – Fracture of talus
  • S92.2 – Fracture of other and unspecified tarsal bone(s)
  • S92.3 – Fracture of metatarsal bone(s)
 
Injury
 
  • S92.0 – Fracture of calcaneus
  • S92.1 – Fracture of talus
  • S92.2 – Fracture of other and unspecified tarsal bone(s)
  • S92.3 – Fracture of metatarsal bone(s)
  • S92.9 – Unspecified fracture of foot and toe
  • S93.1 – Subluxation and dislocation of toe
  • S93.3 – Subluxation and dislocation of foot
 
Diseases
 
  • M93.9 – Osteochondropathy, unspecified
  • M20.1 – Hallux valgus (acquired)
  • M21.4 – Flat foot [pes planus] (acquired)
Osteosynthesis
 
  • S82.1 – Fracture of upper end of tibia
  • S82.2 – Fracture of shaft of tibia
  • S82.3 – Fracture of lower end of tibia
  • S82.4 – Fracture of shaft of fibula
  • S82.5 – Fracture of medial malleolus
  • S82.6 – Fracture of lateral malleolus
  • S82.8 – Other fractures of lower leg
 
Injury
 
  • S82.1 – Fracture of upper end of tibia
  • S82.2 – Fracture of shaft of tibia
  • S82.3 – Fracture of lower end of tibia
  • S82.4 – Fracture of shaft of fibula
  • S86.0 – Injury of Achilles tendon
  • S86.1 – Injury of other muscle(s) and tendon(s) of posterior muscle group at lower leg level
 
Diseases
 
  • M93.9 – Osteochondropathy, unspecified
Endoprosthetics
 
  • M17.0 – Bilateral primary osteoarthritis of knee
  • M17.1 – Unilateral primary osteoarthritis of knee
  • M17.2 – Bilateral post-traumatic osteoarthritis of knee
  • M17.3 – Unilateral post-traumatic osteoarthritis of knee
  • M17.4 – Other bilateral secondary osteoarthritis of knee
  • M17.5 – Other unilateral secondary osteoarthritis of knee
 
Arthroscopy
 
  • S83.2 – Tear of meniscus, current injury
  • S83.3 – Tear of articular cartilage of knee, current
  • S83.4 -Sprain of collateral ligament of knee
  • S83.5 – Sprain of cruciate ligament of knee
  • S83.9- Sprain of unspecified site of knee
  • M17.0 – Bilateral primary osteoarthritis of knee
  • M17.1 – Unilateral primary osteoarthritis of knee
  • M17.2 – Bilateral post-traumatic osteoarthritis of knee
  • M17.3 – Unilateral post-traumatic osteoarthritis of knee
  • M17.4 – Other bilateral secondary osteoarthritis of knee
  • M17.5 – Other unilateral secondary osteoarthritis of knee
  • M23.2 – Derangement of meniscus due to old tear or injury
  • M23.8 – Other internal derangements of knee
  • M24.4 – Recurrent dislocation of joint
  • M25.0 – Hemarthrosis
  • M25.4 – Effusion of joint
 
Injury
 
  • S83.1 – Subluxation and dislocation of knee
  • S83.2 – Tear of meniscus, current injury
  • S83.3 – Tear of articular cartilage of knee, curren
  • S83.4 – Sprain of collateral ligament of knee
  • S83.5 – Sprain of cruciate ligament of knee
  • М23.4 – Loose body in knee
  • М24.0 – Loose body in joint
 
Diseases
 
  • M17.0 – Bilateral primary osteoarthritis of knee
  • M17.1 – Unilateral primary osteoarthritis of knee
  • M17.2 – Bilateral post-traumatic osteoarthritis of knee
  • M17.3 – Unilateral post-traumatic osteoarthritis of knee
  • M17.4 – Other bilateral secondary osteoarthritis of knee
  • M17.5 – Other unilateral secondary osteoarthritis of knee
  • M23.2 – Derangement of meniscus due to old tear or injury
  • M23.8 – Other internal derangements of knee
  • M24.4 – Recurrent dislocation of joint
  • M25.0 – Hemarthrosis
  • M25.4 – Effusion of joint
  • М65 – Synovitis and tenosynovitis
  • М12.2 – Villonodular synovitis (pigmented)
Osteosynthesis
 
  • S82.5 – Fracture of medial malleolus
  • S82.6 – Fracture of lateral malleolus
  • S82.8- Other fractures of lower leg
 
Arthroscopy
 
  • M25.5 – Pain in joint
  • M93.2 – Osteochondritis dissecans
  • M65.9 – Synovitis and tenosynovitis, unspecified
  • M25.0 – Hemarthrosis
  • M25.7 – Osteophyte
 
Injury
 
  • S82.5 – Fracture of medial malleolus
  • S82.6 – Fracture of lateral malleolus
  • S82.8- Other fractures of lower leg
  • S93.0 – Subluxation and dislocation of ankle joint
  • S92.1 – Fracture of talus
 
Diseases
 
  • M87.0 – Idiopathic aseptic necrosis of bone
  • Z89.4 – Distal amputations for the diabetic foot

Reduce the Risk of Complications

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) fracture of osseous or intraosseous fixator screws
b) migration of screws or spokes
c) plate fracture
d) fracture of the intramedullary shaft
e) rupture of the wire seam

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

Testimonials & Quotes

Doctor’s Opinion

Orthopedic Trauma Surgery
Chief of Trauma Division in NYU Langone Health
23+ Yrs Experience

“It gives them immediate feedback and teaches them had to weight bear properly and follow up the follows a program that I prescribed gives me feedback”

Patient Testimonials

Reduce the Risk of Complications

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) fracture of osseous or intraosseous fixator screws
b) migration of screws or spokes
c) plate fracture
d) fracture of the intramedullary shaft
e) rupture of the wire seam

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

Frequently Asked Questions

Can you clarify what physician is using the product you have?

Regarding the physicians using our product, we have been working with orthopedic surgeons and rehabilitation specialists in several leading healthcare institutions.

Why a device on crutches and not in the shoe?

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

How is weight-bearing measured?

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.

How accurate is the data collected from the Smart Crutch device?

The accuracy of Smart Crutch Tips is 98,5%.

What are the minimum and maximum weight-bearing thresholds?

The amount of initial weight bearing can be set from 0% NWB to 50% PWB. The upper threshold for graduated WBAT is 80%.

Smart Crutch Tips can be used with what pathologies and injuries?

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

Are Smart Crutch Tips compatible with canes?

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.

Is it FDA-approved?

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.

Does insurance cover it?

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).

Does Smart Crutch Tips have a warranty?

– 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.  

Could my patients use Smart Crutch Tips during rain?

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.

Smart Crutch Tips System

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ComeBack Mobility
For Doctor

Download Mobile App

ComeBack Mobility
For Doctor

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