Clinical trial NCT03261544: Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?
Official title: Abductor Reattachment Methods in Proximal Femur Replacements: What is the Best Method?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Bone Metastases
Proximal Femur Replacement
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: The Musculoskeletal Tumor Society (MSTS) score
timeFrame: up to 24 months postoperatively
measure: Harris Hip Score
timeFrame: up to 24 months postoperatively
measure: Number of patients with an implant-related complication as reported on the adverse event form upon participation completion.
timeFrame: up to 24 months postoperatively
Secondary outcomes:
measure: Gait Analysis as reported on the study's case report form
timeFrame: up to 24 months postoperatively
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: William Eward, MD, DVM
role: PRINCIPAL_INVESTIGATOR
References: