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

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ClinicalTrials.gov Identifier: NCT02015390
Recruitment Status : Recruiting
First Posted : December 19, 2013
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief 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.


Condition or disease Intervention/treatment Phase
Segmental Long Bone Defects Procedure: Masquelet defect reconstruction Procedure: Titanium cage reconstruction Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comparative Efficacy of the Masquelet Versus Titanium Mesh Cage Reconstruction Techniques for the Treatment of Large Long Bone Deficiencies
Actual Study Start Date : October 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Masquelet defect reconstruction
The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane about a poly(methylmethacrylate)(PMMA) cement spacer within the defect and, following cement removal, autogenous bone grafting (harvested using Reamer-Irrigator-Aspirator) or allogeneic bone graft is used to pack the defect while preserving the biomembrane. The typical time interval between the two stages is 6-8 weeks. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect.
Procedure: Masquelet defect reconstruction
The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects. It involves creating a biomembrane using a PMMA cement spacer within the defect. Subsequently, 6-8 weeks later the cement spacer is removed and the space with the biomembrane is packed with autogenous bone grafting harvested using Reamer-Irrigator-Aspirator (RIA) or allogeneic bone graft. The decision regarding the graft option is left for the treating physician, following the discussion with the patient. The biomembrane serves as a biological enclosure for the graft, and constitutes a source of vascular supply and growth factors, thereby providing an excellent milieu for the graft to consolidate and heal the defect.
Other Name: Masquelet defect reconstruction and bone grating
Procedure: Titanium cage reconstruction
The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. After aseptic defect and soft tissue bed is achieved, the reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using Reamer-Irrigator-Aspirator (RIA) or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Other Name: Titanium mesh cage defect reconstruction with bone grafting
Active Comparator: Titanium cage reconstruction
The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft.
Procedure: Masquelet defect reconstruction
The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects. It involves creating a biomembrane using a PMMA cement spacer within the defect. Subsequently, 6-8 weeks later the cement spacer is removed and the space with the biomembrane is packed with autogenous bone grafting harvested using Reamer-Irrigator-Aspirator (RIA) or allogeneic bone graft. The decision regarding the graft option is left for the treating physician, following the discussion with the patient. The biomembrane serves as a biological enclosure for the graft, and constitutes a source of vascular supply and growth factors, thereby providing an excellent milieu for the graft to consolidate and heal the defect.
Other Name: Masquelet defect reconstruction and bone grating
Procedure: Titanium cage reconstruction
The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. After aseptic defect and soft tissue bed is achieved, the reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using Reamer-Irrigator-Aspirator (RIA) or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Other Name: Titanium mesh cage defect reconstruction with bone grafting



Primary Outcome Measures :
  1. Defect Healing [ Time Frame: 12, 18 months ]
    Radiographic determination of bone defect healing (plain radiography, computed tomography)


Secondary Outcome Measures :
  1. Functional outcomes [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 18 months ]
    Pain (Brief Pain Inventory Short Form); Region-Specific Functional Assessment (Disabilities of the Arm, Shoulder, and Hand; Lower Limb Core Scale);Outcome Survey (Short-Form 36); Time Trade-Off to assess Quality-Adjusted Life Years; Adverse Event Monitoring



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015390


Locations
United States, Texas
The University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Zbigniew Gugala, MD,PhD    409-747-5760    zgugala@utmb.edu   
Contact: Ronald W Lindsey, MD    409-747-5700    rlindsey@utmb.edu   
Principal Investigator: Zbigniew Gugala, MD,PhD         
Principal Investigator: Ronald W Lindsey, MD         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
United States Department of Defense
Investigators
Principal Investigator: Zbigniew Gugala, MD,PhD University o Texas Medical Branch in Galveston, Texas
Principal Investigator: Ronald W Lindsey, MD University o Texas Medical Branch in Galveston, Texas

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02015390     History of Changes
Other Study ID Numbers: 13-100
DoD OR120128 ( Other Identifier: US Department of Defense PRORP )
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by The University of Texas Medical Branch, Galveston:
bone defects
iatrogenic resection
titanium mesh cage
biomembrane
Masquelet technique