Fitmore Hip Stem PMCF Study: A Multi-centre, Non-comparative, Prospective Post-market Clinical Follow-up Study.

Completed

Conditions: Osteoarthritis
Rheumatoid Arthritis
Avascular Necrosis
Prosthesis Failure

Interventions: Device: Fitmore Hip Stem

Registration Number: NCT03411044

Lead Sponsor: Zimmer Biomet

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 420

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with a Fitmore Hip Stem	Fitmore Hip Stem	Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem

Primary Outcome Measures

Name	Time	Method
Radiographic Evaluations	6 - 12 weeks and 7 years	Radiographic evaluation was assessed at the time points listed below in order to identify potential adverse events.
Harris Hip Score	Preop, 6 - 12 weeks, 1 year, 2 year, 3 year, 5 year, 7 and 10 years	The Harris hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care Professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). The total score can vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.
Survivorship	10 years post surgery	The primary endpoint for this study is implant survival at 10 years which is assessed by revision of the Fitmore Hip Stem calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.

Secondary Outcome Measures

Name	Time	Method
EQ5D	Preop, 6-12 weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year	The EuroQol 5 Dimension (EQ-5D) is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, selfcare, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. The Visual Analogue Scale (VAS) is a vertical scale ranges from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health.
SF-12 Physical and Mental Functional Scores	Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year	The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.
Oxford Hip Score	Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year	The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (warst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The Score ranges from 0 - 100 and the outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27.

Trial Locations

Locations (5): Kantonsspital Graubünden
🇨🇭
Chur, Switzerland
Auguste Viktoria Klinik
🇩🇪
Bad Oeynhausen, Germany
Universitätsklinikum Carl Gustav Carus
🇩🇪
Dresden, Germany
Clinica San Michele
🇮🇹
Albenga, Italy
The Yorkshire Clinic
🇬🇧
Bingley, West Yorkshire, United Kingdom