Evaluation of the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur

National, Multicentre, Prospective, Retrospective, Observational Study, to Evaluate the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur

HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture.

The primary objective of this study is to evaluate the performance of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation.

A total of 100 patients from France will be enrolled (until November 2018) and followed up to 24 months.

Study Overview

• Status: Terminated
• Conditions: Bone Metastases; Pathological Fracture of Hip
• Intervention / Treatment: Device: Y-STRUT® (Hyprevention, Pessac, France)

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CHU Caen
  • Paris, France, 75015
    • Hôpital Européen Georges-Pompidou
  • Paris, France, 75020
    • Hopital Tenon - AP-HP
  • Toulouse, France, 31059
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with a Y-STRUT® device to strengthen pre-fractural tumour-induced lesions at the level of the proximal femur.

Description

Inclusion Criteria:

• Patient ≥ 18 years old
• Patient with information form signed to participate in the study;
• Patient presenting a cancer with bone metastases at the level of the proximal femur and having a Y-STRUT® medical device implanted;
• Patient able to complete a questionnaire.

Exclusion Criteria:

• Patient who refuse to participate to this study;
• Patient already enrolled in a clinical study, excluding his participation to HIPPON100.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of post-operative fracture [Performance of the device]	Frequency of patient with a fracture at the implantation site	At 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of post-operative fracture [Performance of the device]	Frequency of patient with a fracture at the implantation site	At 6 and 24 months
Pain [Tolerance of the device]	Self-evaluation of pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum).	immediate post-op, and at 6, 12 and 24 months
Resumption of weight-bearing [Tolerance of the device]	Assessment of resumption of weight-bearing (yes/no at each visit)	immediate post-op, and at 6, 12 and 24 months
Quality of life [Tolerance of the device]	Assessment of the quality of life using EORTC QLQ-C15-PAL questionnaire: the European Organization for Research and Treatment of Cancer (EORTC) has developed the QLQ-C15-PAL questionnaire (quality of life questionnaire with 15 items), a short version of the QLQ-C30 for palliative (PAL) care. Scale ranges go from 15 (better) to 63 points (worse) at the maximum.	pre-operative, immediate post-op, and at 6, 12 and 24 months
Recording of adverse events and device effects [Safety of the device]	Recording of the medical device vigilance: all serious adverse events, all adverse events linked to the device or the operative technique, and any other important event reported.	At 6, 12 and 24 months
Surgical procedure duration [feasibility of the procedure]	Measuring mean/median intervention duration.	At inclusion (day 1)
Hospitalisation duration [feasibility of the procedure]	Measuring mean/median hospitalisation duration.	At inclusion (day 1)
Rates of complications [feasibility of the procedure]	Assessing types and frequencies of procedures complications.	At inclusion (day 1)
Calculation of associated costs [Economic impact of the procedure]	Evaluation of each cost associated with all the collected data linked to the procedure (implantation costs, hospitalisation costs, treatments for pain and other events). Then, the different costs are added together to determine the mean total cost of a procedure.	At the end of the study (24 months from the last included patient)

Collaborators and Investigators

• Sponsor: Hyprevention

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): February 28, 2021
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (ACTUAL): July 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Osteosynthesis; Prophylactic consolidation; Proximal femur
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Spontaneous
• Other Study ID Numbers: HIPPON100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No