Real Life Weight Bearing After Tibial Fractures

NCT03166267 | Completed

• 1 other identifier: SmartFix II - Moticon
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective case series patients with a tibial fracture are monitored with smart biofeedback systems to document the healing progression and real life weight.

Conditions

Tibial Fractures; External Fixation Pin Site Infection

Outcome Measures

Primary Outcomes (1)

• Loading patterns

  Average peak force per step

  Up to 4 months

Secondary Outcomes (3)

• Activity

  Up to 4 months

• Healing

  Up to 4 months

• Pain level

  Up to 4 months

Interventions

External fixator DEVICE

Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients from the participating clinic are invited to participate in the study.

You may qualify if:

• Age 18 years and older
• Diagnosis of tibial fracture (AO 41-43)
• External fracture fixation with large external fixator
• Capable of at least partial weight-bearing
• Bone segment transport (if applicable) must be completed
• Informed consent obtained, i.e.:
• Ability to understand the content of the patient information/ Informed Consent Form (ICF)
• Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
• Signed and dated Ethics Committee (EC)

You may not qualify if:

• External fixation as temporary stabilization
• Bone fragment compression
• Joint-bridging external fixation
• Any not medically managed severe systemic disease
• Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
• Pregnancy or women planning to conceive within the study period
• Prisoner
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (1)

BGU Tübingen

Tübingen, D-72076, Germany

Location

MeSH Terms

Conditions

Tibial Fractures

Interventions

External Fixators

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Stefan Döbele, MD

  BGU Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 25, 2017
• Study Start: May 24, 2018
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: July 6, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)