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Completed

NCT Number: NCT03411044

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

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Auguste Viktoria Klinik, Bad Oeynhausen, Germany

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fitmore Hip Stem

Device

Primary outcomes

  1. Harris Hip Score

    Time frame: 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.

  2. Radiographic Evaluations

    Time frame: 6 - 12 weeks and 7 years

    Radiographic evaluation was assessed at the time points listed below in order to identify potential adverse events.

  3. Survivorship

    Time frame: 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 outcomes

  1. EQ5D

    Time frame: 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.

  2. SF-12 Physical and Mental Functional Scores

    Time frame: 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.

  3. Oxford Hip Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2018
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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