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N/A N=16 Randomized Treatment

Comparative Efficacy of the Masquelet Versus Titanium Mesh Cage Techniques for the Treatment of Large Long Bone Defects

Segmental Long Bone Defects

Enrolled (actual)
16
Serious AEs
20.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Defect Healing - Plain Radiography — 9; 7 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Autogenous RIA bone grafting (Procedure); Allogeneic bone grafting (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The University of Texas Medical Branch, Galveston
Primary completion
Sep 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Defect Healing - Plain Radiography
8; 3
PRIMARY
Number of Participants With Defect Healing - Plain Radiography
8; 3
PRIMARY
Number of Participants With Defect Healing - Plain Radiography
8; 3
PRIMARY
Number of Participants With Defect Healing - Plain Radiography
8; 3
PRIMARY
Number of Participants With Defect Healing - Plain Radiography
8; 3
PRIMARY
Number of Participants With Defect Healing - Plain Radiography
8; 3
PRIMARY
Number of Participants With Defect Healing - Computed Tomography
8; 3
PRIMARY
Number of Participants With Defect Healing - Computed Tomography
8; 3
SECONDARY
Pain Assessment: Brief Pain Inventory
SECONDARY
Pain Assessment: Brief Pain Inventory
SECONDARY
Pain Assessment: Brief Pain Inventory
SECONDARY
Pain Assessment: Brief Pain Inventory
SECONDARY
Pain Assessment: Brief Pain Inventory
SECONDARY
Pain Assessment: Brief Pain Inventory
SECONDARY
Overall Functional Outcome Score
SECONDARY
Overall Functional Outcome Score
SECONDARY
Overall Functional Outcome Score
SECONDARY
Overall Functional Outcome Score
SECONDARY
Overall Functional Outcome Score
SECONDARY
Overall Functional Outcome Score
SECONDARY
Extremity-Specific Outcome Score
SECONDARY
Extremity-Specific Outcome Score
SECONDARY
Extremity-Specific Outcome Score
SECONDARY
Extremity-Specific Outcome Score
SECONDARY
Extremity-Specific Outcome Score
SECONDARY
Extremity-Specific Outcome Score
SECONDARY
Change in Quality of Life: Quality-Adjusted Life-Year

Summary

The United States Department of Defense (DoD) is funding exciting new research at the University of Texas Medical Branch (UTMB) Department of Orthopaedic Surgery and Rehabilitation that can be a major improvement in the treatment of extremity trauma involving segmental bone loss. These devastating injuries occur frequently in both civilians and the military. They typically result from motor vehicle accidents, high-energy fractures, gunshot injuries, and blast injuries, but also from the surgical removal of a bone segment because of infection or tumor. Despite many modern medical advances in this area, bone healing that can adequately replace bone loss and restore pre-injury limb function is extremely difficult to achieve. Existing standard treatment procedures are exceedingly complicated, require highly specialized equipment and clinical skills, and usually require many surgical procedures over many months or years. Despite these effort and costs, major complications usually occur with all the standard treatment options, the patient's ability to return to an acceptable functional status is typically low, and, therefore, many of these patients have their limbs amputated. The UTMB Department of Orthopaedic Surgery and Rehabilitation will conduct a DoD-funded clinical trial to determine and compare the advantages of two new and innovative surgical bone defect treatment techniques that can be significantly more effective for wounded warriors or civilian patients and with these conditions. One treatment method, called "the Masquelet Technique", involves two-stage surgery: the first one to create a biomembrane around the defect by applying a cement spacer, and then the second one for cement spacer removal and defect bone grafting. The other method, developed by UTMB physicians, is "the Cage Technique" and it comprises one-stage surgery in which a special hollow, fenestrated, titanium cage filled with bone graft is implanted in the defect. Initial clinical experience with both of these techniques has been very promising, but to date, there has been no prospective clinical study comparing the two new methods of defect treatment. Identifying an optimal surgical bone defect reconstructive technique would significantly improve the clinical outcomes of patients with these challenging conditions.

Eligibility Criteria

Inclusion Criteria

Presence of an extremity long bone (femur, tibia, humerus, ulna, radius) segmental defect requiring surgical reconstruction with at least one of the following etiologies:

  • traumatic segmental bone defect that warrants surgical reconstruction;
  • acquired bony nonunion (not congenital) treatable by segmental resection and reconstruction;
  • local osteomyelitis (dormant or active) treatable by segmental bone resection and reconstruction;
  • localized, nonmalignant tumor with involvement of bone diaphysis treatable by segmental bone resection and reconstruction.

Exclusion Criteria

  • Non-segmental defects (eg, defect in continuity involving only single cortex);
  • Inability or contraindications to achieve stabilization with an intramedullary (IM) nail;
  • Insufficient defect size (humerus defects <5 cm; femur or tibia defect <2 cm in length);
  • Extremity unsuitable for salvage;
  • Patients with inadequate neuro-vascular status;
  • Defect and/or soft tissue status ineligible for surgical reconstruction;
  • Ipsilateral extremity defect (eg, tibia and femur ipsilateral defects);
  • Skeletal immaturity (open growth plate and/or age <18 years);
  • Known allergic reaction to titanium implants;
  • Disseminated osteomyelitis throughout the bone;
  • Active systemic infection at time of surgery;
  • Congenital / genetic etiology of nonunion (congenital pseudoarthrosis, osteogenesis imperfecta, etc.);
  • Women who are pregnant or nursing;
  • Women who intend to become pregnant during the study followup (ie, 2 years);
  • Disseminated and/or nonresectable malignant tumor involving bone;
  • Patients with active compartment syndrome;
  • Prisoners;
  • Patients considered as non-compliant with medical and follow up care;
  • Patients using narcotics, abusing prescription drugs (within last 2 years);
  • Patients with alcohol abuse;
  • Patients deemed incapable of following instructions pertaining to post operative care due to mental or medical condition;
  • Patients deemed ineligible due to medico-social concerns.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02015390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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