Clinical trial NCT03411044: Fitmore Hip Stem PMCF Study: A Multi-centre, Non-comparative, Prospective Post-market Clinical Follow-up Study.
Official title: Fitmore Hip Stem Post-Market Clinical Follow-Up (PMCF) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Prosthesis Failure
Keywords: Total Hip Arthroplasty
Fitmore
Minimal Invasive Surgery
Short Stem
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-01-25
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from severe hip pain and disability requiring hip surgery using the Fitmore Hip Stem, who meet all of the inclusion criteria and none of the exclusion criteria.

Brief summary: A multi-centre, non-comparative, prospective post-market clinical follow-up study to obtain survival, clinical and radiographic outcomes data on the Zimmer Fitmore Hip Stem.

Detailed description: The objective of this post market surveillance study is to obtain outcome data on the Fitmore Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.

The Fitmore Hip Stem is a short and curved uncemented stem that allows preservation of the greater trochanter and of the gluteal muscles.

Indication/Target Population: Patients suffering from severe hip pain and disability requiring total hip arthroplasty.

Study Design: A multi-centre, non-comparative, prospective post-marketing study.

Targeted Number of Subjects: 500. Data Collection: Collection of preoperative, intra-operative and immediate post-operative data; follow-up visits at 6-12 weeks, 1, 2, 3, 5, 7 and 10 years post-operatively.

Recruitment period: 24 months. Clinical Assessments: Evaluations will be made using the Harris Hip Score, the Oxford Hip Score, the SF-12 Physical and Mental Health summary measures, the EQ-5D (EuroQol) and radiographically.

Safety Assessments: Safety will be assessed by appropriate recording and reporting of adverse events throughout the study. The Fitmore Hip Stem is CE marked, commercially available and has been pre-clinically tested.

Eligibility criteria: Inclusion Criteria:

* Patients who are capable of understanding the doctor"s explanations, following his instructions and who are able to participate in the follow-up program.
* Patients who have given written consent to take part in the study by signing the "Patient Consent Form".
* 18 years minimum.
* Male and female.
* Patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture.

Exclusion Criteria:

* Patients who are unwilling or unable to give consent or to comply with the follow-up program.
* Pregnancy.
* Patients who are skeletally immature.

Primary outcomes:
measure: Harris Hip Score
timeFrame: Preop, 6 - 12 weeks, 1 year, 2 year, 3 year, 5 year, 7 and 10 years
measure: Radiographic Evaluations
timeFrame: 6 - 12 weeks and 7 years
measure: Survivorship
timeFrame: 10 years post surgery
Secondary outcomes:
measure: EQ5D
timeFrame: Preop, 6-12 weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year
measure: SF-12 Physical and Mental Functional Scores
timeFrame: Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year
measure: Oxford Hip Score
timeFrame: Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Auguste Viktoria Klinik
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Albenga
country: Italy
facility: Clinica San Michele
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Bingley
country: United Kingdom
facility: The Yorkshire Clinic
state: West Yorkshire
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: