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NCT03261544 | RECRUITING | Sarcoma


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

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

Sarcoma

Bone Metastases

Proximal Femur Replacement

Intervention/treatment

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 50 participants
Official Title : Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?
Actual Study Start Date : 2017-11-10
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2028-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT03261544


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Locations


RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710

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