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 Type
OBSERVATIONAL
Enrollment
16
The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.
CHU Caen
Caen, France
Hôpital européen Georges-Pompidou
Paris, France
Hopital Tenon - AP-HP
Paris, France
CHU Toulouse
Toulouse, France
Frequency of post-operative fracture [Performance of the device]
Frequency of patient with a fracture at the implantation site
Time frame: At 12 months
Frequency of post-operative fracture [Performance of the device]
Frequency of patient with a fracture at the implantation site
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: At 6, 12 and 24 months
Surgical procedure duration [feasibility of the procedure]
Measuring mean/median intervention duration.
Time frame: At inclusion (day 1)
Hospitalisation duration [feasibility of the procedure]
Measuring mean/median hospitalisation duration.
Time frame: At inclusion (day 1)
Rates of complications [feasibility of the procedure]
Assessing types and frequencies of procedures complications.
Time frame: 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.
Time frame: At the end of the study (24 months from the last included patient)
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