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

NCT03579212 | Terminated DMC

• 1 other identifier: HIPPON100
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 4

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.

Conditions

Pathological Fracture of Hip; Bone Metastases

Keywords

Osteosynthesis; Prophylactic consolidation; Proximal femur

Outcome Measures

Primary Outcomes (1)

• Frequency of post-operative fracture [Performance of the device]

  Frequency of patient with a fracture at the implantation site

  At 12 months

Secondary Outcomes (9)

• Frequency of post-operative fracture [Performance of the device]

  At 6 and 24 months

• Pain [Tolerance of the device]

  immediate post-op, and at 6, 12 and 24 months

• Resumption of weight-bearing [Tolerance of the device]

  immediate post-op, and at 6, 12 and 24 months

• Quality of life [Tolerance of the device]

  pre-operative, immediate post-op, and at 6, 12 and 24 months

• Recording of adverse events and device effects [Safety of the device]

  At 6, 12 and 24 months

Interventions

Y-STRUT® (Hyprevention, Pessac, France) DEVICE

The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient who refuse to participate to this study;
• Patient already enrolled in a clinical study, excluding his participation to HIPPON100.

Sponsors & Collaborators

• Hyprevention: lead

Study Sites (4)

CHU Caen

Caen, 14033, France

Location

Hôpital européen Georges-Pompidou

Paris, 75015, France

Location

Hopital Tenon - AP-HP

Paris, 75020, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: July 6, 2018
• Study Start: November 1, 2016
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: April 14, 2021

Record last verified: 2020-06

Locations

FR (4)