Health TrialsbyHealthPanel

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

ConditionMetastatic Bone Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMichelle Ghert, MD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Life expectancy of at least 6 months

Lesions in the proximal femur (femoral neck, intertrochanteric region, subtrochanteric region, and combinations thereof)

Low or intermediate risk for perioperative morbidity and/or mortality

No more than 75% and no less than 25% bone loss

Disqualifiers

Lesions isolated to the femoral neck

Lesion with any femoral head involvement

High risk for perioperative morbidity and/or mortality

Multidisciplinary decision that resection of the entire lesion would be indicated

Trial design

Design model

Parallel

Treatments tested in this trial

  • Internal Fixation

    Procedure/Surgery

    Internal Fixation

  • Resection and reconstruction

    Procedure/Surgery

    Resection and reconstruction

Treatment groups

334 Participants
are divided into 2 treatment groups
Group A: Resection and ReconstructionExperimental treatment 1 intervention
Group B: Internal FixationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mortality at 12 months

Collected through case report forms via electronic medical records and patient/ caregiver self-reported.

Time frame
From enrollment to one year follow-up post surgery.
2

Physical function

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)

Time frame
From enrollment to one year follow-up post surgery.
3

Number of days at home

Patient self- reported via patient diary.

Time frame
From enrollment to one year follow-up post surgery.

Secondary outcomes

1

Quality of life- PROMIS-PROPr (PROMIS-Preference) health utility score

PROMIS-PROPr (PROMIS-Preference) utility score - encompassing mental and physical health, and quality of life. The PROMIS-PROPr combines scores from seven PROMIS domains into a single preference-based score (also called a health utility score), which captures the preferences of the general adult population. The total number of items that the patient answers are 31. This instrument gives four different scores: health utility score, domain level scores (one for each of the following domains: physical function, anxiety, depression, fatigue, sleep disturbance, social roles and activities, pain interference, cognition, and pain intensity), physical component score, and a mental component score. Answer options include: Not at all (1); A little bit (2); Somewhat (3); Quite a bit (4); Very much (5).

Time frame
From enrollment to one year follow-up post surgery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Michelle Ghert, MD

Lead sponsor

McMaster University

Sponsor institution

Canadian Cancer Society (CCS)

Collaborator

Source ClinicalTrials.gov
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