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

NCT03411044 | Completed Results FDA Device

• 1 other identifier: 09H06
• Study Type: observational
• Target: 420
• Locations: 4 countries
• Sites: 5

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.

Conditions

Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Prosthesis Failure

Keywords

Total Hip Arthroplasty; Fitmore; Minimal Invasive Surgery; Short Stem

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• EQ5D

  Preop, 6-12 weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year

• SF-12 Physical and Mental Functional Scores

  Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year

• Oxford Hip Score

  Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year

Study Arms (1)

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

Interventions

Fitmore Hip Stem DEVICE

Subjects with a Fitmore Hip Stem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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".
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

Auguste Viktoria Klinik

Bad Oeynhausen, 32545, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Clinica San Michele

Albenga, 17031, Italy

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

The Yorkshire Clinic

Bingley, West Yorkshire, BD16 1TW, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Prosthesis Failure

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Postoperative Complications

Limitations and Caveats

Due to the COVID 19 pandemic, many study patients could not return for the 10 year follow up resulting to drop out. In addition, one study site which enrolled 80 cases could not continue to follow the study patients at the 7 year follow up due to lack of resources to continue the study.

Results Point of Contact

• Title: Esther Foo
• Organization: Zimmer Biomet

esther.foo@zimmerbiomet.com

+41787183202

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: February 8, 2008
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: November 5, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-11

Locations

GB (1); IT (1); DE (2); CH (1)