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Completed

NCT Number: NCT04542174

PMCF 8 Year Results TRJ®

The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results

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Key information

Conditions

Arthroplasty, Replacement, Hip Follow-up Study

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dreifaltigkeitskrankenhaus Köln

Cologne, 50933, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients have received a TRJ® prosthesis in 2012
  • Patient did participate in the 2 years results evaluation 2014
  • Patient gave his written consent for study participation

Exclusion criteria

  • patient is pregnant
  • patient < 18 years

Treatment and study plan

Primary outcomes

  1. Survival rate of the stem

    Time frame: at follow-up examination approximately 8 years after primary intervention

    The survival of the TRJ® stem prosthesis will be analyzed using the "Kaplan-Meier". Isolated revisions of the inlay and / or of the acetabular components (with the stem being kept in place) are documented, but assessed separately.

Secondary outcomes

  1. Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)

    Time frame: at follow-up examination approximately 8 years after primary intervention

    The Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) is a 40 items patient reported outcome score (PROM) designed specifically to evaluate the physical functionality of hip osteoarthritis patients. The HOOS offers 5 subgroups, each with 100 points as best result.

  2. Harris Hip Score (HHS)

    Time frame: at follow-up examination approximately 8 years after primary intervention

    The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities.

  3. Rate of Adverse and Serious Adverse Events

    Time frame: at follow-up examination approximately 8 years after primary intervention

    All Adverse Events (AE) / Serious Adverse Events (SAE) either observed during the follow-up examination, found in the patient file of the hospital or reported by the patient will be documented. Only those AE and SAE that could be related to the investigational product or the TRJ® Total Hip Arthroplasty procedure in 2012 are of interest.

  4. Pain Assessment

    Time frame: at follow-up examination approximately 8 years after primary intervention

    Pain will be measured with a Visual Analogue Scale (VAS), at rest and when walking on flat ground. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line.

  5. Radiological Outcome: Inlay wear

    Time frame: at follow-up examination approximately 8 years after primary intervention

    Inlay wear is assessed on AP x-rays of the cup and will be analysed according to the zones defined by DeLee and Charnley. "Charnley" and "Gruen" zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements.

  6. Radiological Outcome: Bony Osseointegration or conspicuous features of the cup

    Time frame: at follow-up examination approximately 8 years after primary intervention

    Bony Osseointegration or conspicuous features of the Cup are assessed on anterior-posterior x-rays of the cup and will be analysed according to the zones defined by DeLee and Charnley. "Charnley" and "Gruen" zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements.

  7. Radiological Outcome: Migration of the stem in mm

    Time frame: at follow-up examination approximately 8 years after primary intervention

    Migration of the stem is assessed in [mm] relative to discharge x-rays

  8. Radiological Outcome: Bone resorption at the medial stem neck

    Time frame: at follow-up examination approximately 8 years after primary intervention

    Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem

  9. Radiological Outcome: Bone resorption at the Trochanter Major

    Time frame: at follow-up examination approximately 8 years after primary intervention

    Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem

  10. Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem

    Time frame: at follow-up examination approximately 8 years after primary intervention

    Bony Osseointegration or conspicuous features of the stem are assessed on anterior-posterior and lateral x-rays of the stem and will be analysed according to the zones defined by Gruen. "Charnley" and "Gruen" zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements

  11. Radiological Outcome: Heterotopic Ossification

    Time frame: at follow-up examination approximately 8 years after primary intervention

    Brooker classification divides heterotopic ossifications that form following total hip replacement to four classes. Class I: islands of bone within soft tissues around hip; Class II: bone spurs in pelvis or proximal end of femur leaving ≥1 cm between the opposing bone surfaces; Class III: bone spurs that extend from pelvis or the proximal end of femur, which reduce the space between the opposing bone surfaces to <1cm; Class IV: ankylosis of the hip on x-ray

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Prospective Non-Interventional Post Market Clinical Follow-up Study TRJ® - 8 Years Results

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Jan 14, 2022

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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