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Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?

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ClinicalTrials.gov Identifier: NCT03261544
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique. The investigators hypothesize that those patients who receive reattachment of the abductors directly into the prosthesis will have better functional outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective, and reproducible method to assess abductor function at clinical post-operative visits through plain radiographs.

Condition or disease Intervention/treatment
Sarcoma Bone Metastases Proximal Femur Replacement Procedure: Proximal Femur Replacement

Detailed Description:
Patients treated for proximal femur replacements at Duke University Medical Center by Orthopaedic Oncology trained surgeons. The Duke DEDUCE database will be used to identify retrospective patients using the above mentioned CPT codes. Individual chart review of the electronic medical record will then be used to identify those receiving a proximal femur replacement. Maximum number of charts to be reviewed in the study will be 300. Of these 300 charts, the investigators plan to consent 25 subjects who have return appointments scheduled. The investigators also plan to consent 25 preoperative patients, for a total of 50 subjects.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Proximal Femur Replacement
The proximal femur is a common site for primary bone sarcomas and metastatic disease. The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.
Procedure: Proximal Femur Replacement
The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.




Primary Outcome Measures :
  1. Gait Analysis [ Time Frame: up to 12 months postoperatively ]
    gait analysis as measured by software in gait lab


Secondary Outcome Measures :
  1. Functional Outcome Questionnaire [ Time Frame: up to 5 years postoperatively ]
    outcome questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for proximal femur replacements at Duke University Medical Center by Orthopaedic Oncology trained surgeons. The Duke DEDUCE database will be used to identify retrospective patients using the above mentioned CPT codes. Individual chart review of the electronic medical record will then be used to identify those receiving a proximal femur replacement. Maximum number of charts to be reviewed in the study will be 300. Of these 300 charts, the investigators plan to consent 25 subjects who have return appointments scheduled. The investigators also plan to consent 25 preoperative patients, for a total of 50 subjects.
Criteria

Inclusion Criteria:

• Has undergone or is scheduled for proximal femur replacement by an Ortho Oncology surgeon

Exclusion Criteria:

  • Non-ambulatory before or after the procedure
  • Subjects who, in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up

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): NCT03261544


Contacts
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Contact: Cameron Howes, BA 9196135747 cameron.howes@duke.edu

Locations
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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Cameron Howes         
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03261544     History of Changes
Other Study ID Numbers: Pro00082717
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No