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

Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03579212
• Other study ID #: HIPPON100
• Status: Terminated
• Start date: November 2016
• Est. completion date: February 28, 2021

Study information

• Verified date: June 2020
• Source: Hyprevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Metastases
• Hip Fractures
• Pathological Fracture of Hip

Intervention

Device:
• Y-STRUT® (Hyprevention, Pessac, France)
The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.

Locations

Country	Name	City	State
France	CHU Caen	Caen
France	Hôpital européen Georges-Pompidou	Paris
France	Hopital Tenon - AP-HP	Paris
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Hyprevention

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of post-operative fracture [Performance of the device]	Frequency of patient with a fracture at the implantation site	At 12 months
Secondary	Frequency of post-operative fracture [Performance of the device]	Frequency of patient with a fracture at the implantation site	At 6 and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Surgical procedure duration [feasibility of the procedure]	Measuring mean/median intervention duration.	At inclusion (day 1)
Secondary	Hospitalisation duration [feasibility of the procedure]	Measuring mean/median hospitalisation duration.	At inclusion (day 1)
Secondary	Rates of complications [feasibility of the procedure]	Assessing types and frequencies of procedures complications.	At inclusion (day 1)
Secondary	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)