Fracture of Hip, Osteoporosis
Conditions
Keywords
Osteosynthesis, Prophylactic consolidation, Proximal femur
Brief summary
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.
Interventions
The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.
Sponsors
Hyprevention
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient of 60 years and older, according to CE indication; * Patient with information form signed to participate in the study; * Patients presenting a first low energy hip fracture on one side and having a Y-STRUT® device implanted on the contralateral hip between 0 and 120 days after the treatment of the fracture of the first hip;
Exclusion criteria
* Patient who refuse to participate to this study; * Patient implanted with Y-STRUT® for another indication; * Patient already enrolled in a clinical study, excluding his participation to HIP50.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of post-operative fracture [Clinical efficacy of the device] | At 12 months | Frequency of Y-STRUT® implanted patients with a fracture at the implantation site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recording of concomitants treatments [safety and feasibility of the device] | At 3, 12 and 24 months | Recording of all concomitants treatments: analgesic for pain, anti-osteoporotic treatment and other treatments. |
| Pain [safety and feasibility of the device] | At 3, 12 and 24 months | Self-evaluation of hip pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum). |
| Walking conditions [safety and feasibility of the device] | At 3, 12 and 24 months | Assessment of resumption of weight-bearing (yes/no, aid) |
| Frequency of post-operative fracture [Clinical efficacy of the device] | At 3 and 24 months | Frequency of Y-STRUT® implanted patients with a fracture at the implantation site |
| Surgical procedure duration [learning curve of the procedure] | At the end of the inclusion period (24 months from the first included patient) | Measuring mean/median intervention duration of each procedure. Then, all the durations of successive procedures will be compared among all the investigators. |
| Hospitalisation duration [learning curve of the procedure] | At the end of the inclusion period (24 months from the first included patient)] | Measuring mean/median hospitalisation duration. Then, all the durations of successive hospitalisations will be compared among all the investigators. |
| Rate of complications [learning curve of the procedure] | At the end of the inclusion period (24 months from the first included patient) | 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. |
| Recording of adverse events and device effects [safety and feasibility of the device] | At 3, 12 and 24 months | 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. |
Countries
France
Outcome results
None listed