Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Internal Fixation: Internal Fixation

Resection and reconstruction: Resection and reconstruction

Study summary

The goal of this clinical trial is to find out if removing and replacing part of the hip bone works better than using metal hardware to stabilize the bone in patients whose cancer has spread to the hip. The main questions are:

1. Does removing and replacing part of the bone work better than just stabilizing it with metal hardware?
2. Does removing and replacing the bone help reduce problems like cancer coming back or the metal hardware breaking?

Researchers will compare two treatments: using metal rods and plates to stabilize the bone (internal fixation) versus removing part of the bone and possibly replacing the hip joint (resection and reconstruction) to see if the second option causes fewer problems.

Participants will:

* Be randomly assigned to one of two groups (internal fixation or resection and reconstruction).
* Have one of the two surgeries based on which group they're in.
* Go to follow-up appointments with the study doctor at 2 weeks, 6 weeks, 4 months, 6 months, 9 months, and 12 months after surgery.

Eligibility

Primary outcome measure(s)

• Mortality at 12 months — From enrollment to one year follow-up post surgery.
  Collected through case report forms via electronic medical records and patient/ caregiver self-reported.
• Physical function — From enrollment to one year follow-up post surgery.
  Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Physical Function score: To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair? Answer options include: Completely (best outcome); Mostly; Moderately; A little; Not at all (worst outcome)
• Number of days at home — From enrollment to one year follow-up post surgery.
  Patient self- reported via patient diary.

Trial sites (13)