Clinical Trials Logo
  1. Home
  2. Bone Cancer
  3. NCT00160758
  4. Details
NCT00160758 Clinical Trial

Physical Characteristics of Retrieved Massive Allografts

Bone Cancer Clinical Trial

Official title:
Physical Characteristics of Retrieved Massive Allografts

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00160758
Other study ID # 214-1999
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated October 26, 2012
Start date December 1999
Est. completion date September 2009

Study information
Verified date October 2012
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This purpose of this study is to measure the strength of tissue allografts that have been in the body various lengths of time.

Description:

Allograft bone is the primary source of graft material for large skeletal defects resulting from trauma, disease, oncological resection, or reconstruction of failed total joint arthroplasties. The physical characteristics of such grafts after various intervals of remodeling and incorporation in vivo have never been studied.

The purpose of this study is to obtain tissue from allografts retrieved at autopsy, at amputation for oncological complications and from patients undergoing revision procedures for failed allograft transplantation. We will evaluate the mechanical properties, histomorphometric indices and presence of microfractures.

Our hypotheses are:

- histomorphometric parameters of porosity and microfracture density will predict allograft strength,

- microfracture density will be correlated with time in vivo and allograft strength,

- the rate of host-allograft nonunion and fracture will correlate with radiation therapy and chemotherapy.

The retrieved tissue will be processed using standard undecalcified histology and quantitatively assessed for degree of incorporation, allograft porosity, and microfracture density. The biomechanical characteristics of the bulk allograft and allograft-host junction will be quantified and compared to allograft bone prior to transplantation.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- failed allograft bone

- removal of allograft due to oncological complications

- amputation due to oncological complications

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• retrieve massive allograft
Allograft constructs removed because of infection or cancer complications will be retained for biomechanical testing

Locations
Country Name City State
United States UF Orthopaedics and Sports Medicine Institute Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Recruiting NCT03905174 - Massive Implants the Next Generation N/A
Completed NCT00160719 - HLA Sensitization Following Major Cortical Allograft Bone Procedures Phase 4
Completed NCT04974008 - Osteosarcoma Maintenance Therapy With OST31-164 Phase 2
Not yet recruiting NCT06070259 - Insights Into Participating in Studies for Bone Cancer
Completed NCT01553539 - Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery Phase 2
Recruiting NCT03160274 - Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Active, not recruiting NCT02880319 - Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone Phase 2
Completed NCT01135849 - B-Receptor Signaling in Cardiomyopathy N/A
Terminated NCT00960063 - A Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Pediatric Participants With Advanced Solid Tumors (P05883, MK-7454-006) Phase 1
Terminated NCT02443103 - Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis N/A
Recruiting NCT04028479 - The Registry of Oncology Outcomes Associated With Testing and Treatment
Terminated NCT03525392 - Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1. Phase 1
Terminated NCT01541358 - Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer N/A
Terminated NCT01313884 - Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma Phase 2
Completed NCT01091883 - Study Comparing the Safety and Effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) and External Beam Radiation (EBRT) for Treatment of Metastatic Bone Tumors and Multiple Myeloma N/A
Terminated NCT00127387 - Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia Phase 2/Phase 3
Not yet recruiting NCT03106675 - MR Imaging- Guided High Intensity Focused Ultrasound (HIFU) Therapy of Bone Metastases N/A
Recruiting NCT05830084 - Phase Ib / Regorafenib With Conventional Chemotherapy/Newly Diagnosed Patients/ Multimetastatic Ewing Sarcoma Phase 1
Completed NCT01085565 - Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System Phase 2
Recruiting NCT04307914 - Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases N/A