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OpenTrials
Completed

NCT Number: NCT05810584

Revision LR Femoral Stem for Hip Replacement

This is a post-market, monocentric Retrospective and prospective, observational, open-label and baseline clinical study in order to evaluate the performance and safety of Revision LR femoral stem

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Key information

Conditions

Hip Arthropathy Musculoskeletal Diseases Orthopedic Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.S.S.T Spedali Civili di Brescia

Brescia, Italy

Who can participate

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

Inclusion criteria

  • Males and females of any race
  • Age ≥ 18 years old
  • A diagnosis or condition in the target hip of one or more of the following: Primary tumors or metastasis and relative outcomes; Advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;Fracture or avascular necrosis; Congenital or acquired deformity; Failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty; Epiphyseal region general trauma, Willingness to comply with prescribed rehabilitation and study evaluation and ability to return for follow-up visits
  • Signed study-specific Informed Consent Form

Exclusion criteria

  • Acute or chronic infections, local or systemic infections,
  • Septicaemia
  • Persistent acute or chronic osteomyelitis
  • Serious muscular, neurological or vascular diseases affecting the concerned limb
  • Mass higher than 60 kg

Treatment and study plan

Revision LR femoral stem

Device

Revision LR is a modular femoral stem used for hip replacement

Primary outcomes

  1. Revision rate of the femoral component

    Time frame: from baseline to FU 10 Years

    Revision rate of the femoral component for aseptic loosening, not resultant from a tumor recurrence.

Secondary outcomes

  1. Implant stability

    Time frame: from baseline to FU 10 Years

    Implant stability via radiographic assessment of the X-rays at followup, using immediate postoperative X-rays as baseline;

  2. Functionality evaluation

    Time frame: from baseline to FU 10 Years

    Functionality of the patients measured via Harris Hip Score up to last available FU

  3. Incidence of device-related adverse events or serious adverse events.

    Time frame: from baseline to FU 10 Years

    Incidence of device-related adverse events or serious adverse events

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Official study title

A Retrospective and Prospective Clinical Study Evaluating Safety and Performance of Revision LR Stem in Total Hip Arthroplasty (THA)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2023
Registry last updated
Apr 19, 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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