An observational study in Fracture of Hip and Osteoporosis, sponsored by Hyprevention. Terminated at 5 sites in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-04-29.
Sponsored by Hyprevention · Observational
HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal femur as percutaneous internal fixation to prevent contralateral hip fracture in case of osteoporosis.
The primary objective of this study is to evaluate the clinical efficacy 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 50 patients from France will be enrolled (until December 2020) and followed up to 24 months.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 10 is below the median of 174 across 446 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Hyprevention is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal femur as percutaneous internal fixation.
Exclusion Criteria:
The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.
Frequency of post-operative fracture [Clinical efficacy of the device]
Frequency of Y-STRUT® implanted patients with a fracture at the implantation site
Time frame: At 12 months
Frequency of post-operative fracture [Clinical efficacy of the device]
Frequency of Y-STRUT® implanted patients with a fracture at the implantation site
Time frame: At 3 and 24 months
Recording of concomitants treatments [safety and feasibility of the device]
Recording of all concomitants treatments: analgesic for pain, anti-osteoporotic treatment and other treatments.
Time frame: At 3, 12 and 24 months
Pain [safety and feasibility of the device]
Self-evaluation of hip pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum).
Time frame: At 3, 12 and 24 months
Walking conditions [safety and feasibility of the device]
Assessment of resumption of weight-bearing (yes/no, aid)
Time frame: At 3, 12 and 24 months
Recording of adverse events and device effects [safety and feasibility 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 3, 12 and 24 months
Surgical procedure duration [learning curve of the procedure]
Measuring mean/median intervention duration of each procedure. Then, all the durations of successive procedures will be compared among all the investigators.
Time frame: At the end of the inclusion period (24 months from the first included patient)
Hospitalisation duration [learning curve of the procedure]
Measuring mean/median hospitalisation duration. Then, all the durations of successive hospitalisations will be compared among all the investigators.
Time frame: At the end of the inclusion period (24 months from the first included patient)]
Rate of complications [learning curve of the procedure]
Assessing types and frequencies of procedures complications (per-op and post-op). Then, all the rate of complications will be compared among all the investigators.
Time frame: At the end of the inclusion period (24 months from the first included patient)
This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Hyprevention