Hip Prospective Study

Societe dEtude, de Recherche et de Fabrication5,000 enrolled

Overview

In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017/745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable. Therefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses. HiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Hip Arthropathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female adults * Planned to be implanted with investigational medical devices per the IFUs: * Implantation in skeletally mature adults (usually aged 60-65 and over), with an extremely painful and/or disabled joint and insufficiently improved by alternative treatment options after an observation period lasting from a few weeks to a few months * Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer) * For an intended purpose and indication listed in the IFUs * Affiliated to French social security * Who provided a dated and signed informed consent form Exclusion Criteria: * Patient protected by a French legal measure * Patient not able to express his/her consent as deemed by the investigator * Patient deprived of liberty or hospitalized without consent * Pregnant or breastfeeding women * Patient contraindicated to investigational medical devices implantation per the IFUs * Patient contraindicated to radiographic follow-up * Patient a priori not able to meet the follow-up visits as deemed by the investigator * Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.

Outcomes

Primary Outcomes

Survival rate

To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration

Time frame: Per operative period to 15 years

Secondary Outcomes

Intermediate survival rates

To assess the survival rate of the investigational medical devices at the intermediate timepoints

Time frame: Per operative period to 10 years

Functional improvement

To assess the evolution of patient's functional capacity post-implantation using HOOS score

Time frame: Per operative period to 15 years

Functional improvement

To assess the evolution of patient's functional capacity post-implantation using Harris Hips score

Time frame: Per operative period to 15 years

Functional improvement

To assess the evolution of patient's activity post-implantation using UCLA scale

Time frame: Per operative period to 15 years

Functional improvement

To assess the evolution of patient's activity post-implantation using Charnley score

Time frame: Per operative period to 15 years

Leg length discrepancy

To assess patient's leg length discrepancy post-implantation (visual evaluation)

Time frame: Pre operative period to 15 years

Patient's Pain

To assess patient's pain (Visual Analogic Scale)

Time frame: Pre operative period to 15 years

Patient's quality of life

To assess patient's quality of life post-implantation (Forgotten Joint Score)

Time frame: Pre operative period to 15 years

Patient's satisfaction

To assess patients' satisfaction with the operation (4-points question)

Time frame: Post operative period to 15 years

Surgeon's satisfaction

To assess surgeons' satisfaction with the operation

Time frame: Per operative period to 15 years

Adverse events

To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery

Time frame: Per operative period to 15 years

Hip Prospective Study

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts