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

Fitmore Hip Stem Post-Market Clinical Follow-Up (PMCF) Study

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Prosthesis Failure
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 420

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Auguste Viktoria Klinik
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus
• Italy
  • Albenga, Italy, 17031
    • Clinica San Michele
• Switzerland
  • Chur, Switzerland, 7000
    • Kantonsspital Graubunden
• United Kingdom
  • West Yorkshire
    • Bingley, West Yorkshire, United Kingdom, BD16 1TW
      • The Yorkshire Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with a Fitmore Hip Stem; Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem.	Device: Fitmore Hip Stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score	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.	Preop, 6 - 12 weeks, 1 year, 2 year, 3 year, 5 year, 7 and 10 years
Radiographic Evaluations	Radiographic evaluation was assessed at the time points listed below in order to identify potential adverse events.	6 - 12 weeks and 7 years
Survivorship	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.	10 years post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D	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.	Preop, 6-12 weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year
SF-12 Physical and Mental Functional Scores	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.	Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year
Oxford Hip Score	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.	Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2008
• Primary Completion (Actual): June 10, 2023
• Study Completion (Actual): June 10, 2023

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Minimal Invasive Surgery; Fitmore; Short Stem
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Necrosis; Prosthesis Failure
• Other Study ID Numbers: 09H06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No