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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03579212
Other study ID # HIPPON100
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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.

Study Design


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)
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