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

• ClinicalTrials.gov Identifier: NCT03579212
• Recruitment Status: Terminated
• First Posted: July 6, 2018
• Last Update Posted: April 14, 2021
• Sponsor: Hyprevention
• Information provided by (Responsible Party): Hyprevention

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Pathological Fracture of Hip; Bone Metastases	Device: Y-STRUT® (Hyprevention, Pessac, France)

Study Design

• Study Type: Observational
• Actual Enrollment: 16 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: February 28, 2021
• Actual Study Completion Date: February 28, 2021

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Frequency of post-operative fracture [Performance of the device] [ Time Frame: At 12 months ]
   Frequency of patient with a fracture at the implantation site

Secondary Outcome Measures :

1. Frequency of post-operative fracture [Performance of the device] [ Time Frame: At 6 and 24 months ]
   Frequency of patient with a fracture at the implantation site
2. Pain [Tolerance of the device] [ Time Frame: immediate post-op, and at 6, 12 and 24 months ]
   Self-evaluation of pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum).
3. Resumption of weight-bearing [Tolerance of the device] [ Time Frame: immediate post-op, and at 6, 12 and 24 months ]
   Assessment of resumption of weight-bearing (yes/no at each visit)
4. Quality of life [Tolerance of the device] [ Time Frame: pre-operative, immediate post-op, and at 6, 12 and 24 months ]
   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.
5. Recording of adverse events and device effects [Safety of the device] [ Time Frame: At 6, 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.
6. Surgical procedure duration [feasibility of the procedure] [ Time Frame: At inclusion (day 1) ]
   Measuring mean/median intervention duration.
7. Hospitalisation duration [feasibility of the procedure] [ Time Frame: At inclusion (day 1) ]
   Measuring mean/median hospitalisation duration.
8. Rates of complications [feasibility of the procedure] [ Time Frame: At inclusion (day 1) ]
   Assessing types and frequencies of procedures complications.
9. Calculation of associated costs [Economic impact of the procedure] [ Time Frame: At the end of the study (24 months from the last included patient) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with a Y-STRUT® device to strengthen pre-fractural tumour-induced lesions at the level of the proximal femur.

Criteria

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.

Contacts and Locations

Locations

France

CHU Caen

Caen, France, 14033

Hôpital européen Georges-Pompidou

Paris, France, 75015

Hopital Tenon - AP-HP

Paris, France, 75020

CHU Toulouse

Toulouse, France, 31059

Sponsors and Collaborators

Hyprevention

More Information

• Responsible Party: Hyprevention
• ClinicalTrials.gov Identifier: NCT03579212
• Other Study ID Numbers: HIPPON100
• First Posted: July 6, 2018
• Last Update Posted: April 14, 2021
• Last Verified: June 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hyprevention:

Osteosynthesis; Prophylactic consolidation; Proximal femur

Additional relevant MeSH terms:

Fractures, Spontaneous; Hip Fractures; Fractures, Bone; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries