Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails (EPSOCOT)

Evaluation of the Management of Bone Loss in Orthopaedic Surgery Using the Masquelet Technique or Transport Nails

This is a single-center prospective observational study comparing two techniques for reconstructing bone loss in the lower limbs. The aim of the study was to compare the results of reconstructions using the Masquelet technique with reconstructions using electromagnetic transport nails. The primary endpoint was time to bone healing. This study is the first prospective descriptive study of electromagnetic transport nails.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical-size Bone Defect
• Intervention / Treatment: Other: Data collection and self-administered questionnaire.

Detailed Description

Segmental bone defects pose a major challenge in orthopaedics due to various causes like trauma, oncology resections, or chronic osteomyelitis. Reconstruction techniques are complex, with Masquelet's method being the most widely used in France, despite mixed outcomes and complications. A novel electromagnetic bone transport technique via intramedullary nailing has emerged as a promising alternative. The primary goal of the study is to compare consolidation times between these two approaches for metaphyseal-diaphyseal bone loss in the lower limbs. Secondary objectives include assessing patient demographics, functional outcomes, quality of life, hospital stays, and adverse events.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin BOUYER, PROF; Phone Number: +335 56 79 87 18; Email: b.bouyer@chu-bordeaux.fr
• Study Contact Backup: Name: Romain HUGUET; Email: romain.huguet@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux
    • Contact: Benjamin BOUYER, PROF; Phone Number: +335 56 79 87 18; Email: b.bouyer@chu-bordeaux.fr
    • Contact: Anaïs DELGOVE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient ≥ 18 years
• Minor patient, able to consent to data collection, with the consent of the owner(s)

• Patient consulting for a medical reason involving a loss of bone substance in the lower limb in an investigating centre linked to one of these aetiologies for which a reconstruction procedure using a transport nail or Masquelet technique is envisaged:

  • Tumour pathologies requiring
  • Septic or aseptic pseudarthrosis
  • Traumatic pathology
  • Infectious pathologies

Exclusion Criteria:

• Patients under guardianship or curatorship,
• Individuals deprived of their liberty by judicial or administrative decision,
• Individuals receiving involuntary psychiatric care requiring the consent of their legal representative,
• Individuals unable to express their consent,
• Individuals under legal protection,
• Patients with an indication for bone reconstruction using a technique other than the Masquelet technique and nail transport,
• Patients not covered by a social security scheme,
• Patients ineligible for bone reconstruction due to their comorbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Masquelet's method; Patient consulting for a medical reason involving a loss of bone substance in the lower limb in an investigating centre linked to one of these aetiologies for which a reconstruction procedure using a Masquelet technic is envisaged	Other: Data collection and self-administered questionnaire.; Exhaustive collection of data in a health data warehouse: collection of clinical, radiological examinations (standard of care), functionals scores and self- administered questionnaire (quality of life).
Other: Transport nail; Patient consulting for a medical reason involving a loss of bone substance in the lower limb in an investigating centre linked to one of these aetiologies for which a reconstruction procedure using a transport nail is envisaged	Other: Data collection and self-administered questionnaire.; Exhaustive collection of data in a health data warehouse: collection of clinical, radiological examinations (standard of care), functionals scores and self- administered questionnaire (quality of life).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of radiological consolidation	Radiological consolidation is defined by an anteroposterior and lateral radiograph showing at least three out of four cortical plates consolidated. This assessment is performed during follow-up by the physician treating the patient and will be confirmed by an evaluation committee at a later stage.	From enrollment to 36 months after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcomes : score MSTS	Functional recovery assessed using MSTS (Musculoskeletal Tumor Society Score). It is composed of 6 items , each item on a scale of 0 to 5, with a higher score indicating better function. The total score, ranging from 0 (maximum disability) to 30 (no disability), can be converted to a point scale from 0 to 100.	Baseline, 12 months, 24 months and 36 months
Time to full weight-bearing	Time from initial reconstructive surgery to full weight-bearing without assistive devices, as assessed during routine clinical follow-up.	Baseline, 3 months, 6 months, 12 months, 24 months and 36 months
. Functional outcomes : score LEFS	Functional recovery assessed using Lower Extremity Functional Scale (LEFS). It is composed of 20 items , each item on a scale of 0 to 4, with a higher score indicating better function and total score from 0 to 80.	Baseline, 12 months, 24 months and 36 months
Functional outcomes : paley Marr score.	Functional recovery assessed using Paley-Maar score. This score is defined from "excellent" to "poor"in fonction of pain, autonomous, ....	Baseline, 12 months, 24 months and 36 months
Quality of life	Health-related quality of life evaluated using the SF-36 questionnaire. This questionnaire is composed of 11 items and total score from 0 to 100.	Baseline, 12 months, 24 months and 36 months
Adverse events and complications	Occurrence and type of adverse events and complications, including infections, mechanical failures, nonunion, and need for revision surgery.	3 months, 6 months, 12 months, 24 months and 36 months
Bone consolidation rate	Proportion of patients achieving radiological bone consolidation, defined as healing of at least 3 of 4 cortices on standard anteroposterior and lateral radiographs.	From enrollment to 36 months after

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Benjamin BOUYER, PROF, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2034

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Masquelet technique; Distraction osteogenesis; Bone transport; Critical-size bone defects; Induced-membrane technique
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: CHUBX2025/061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No