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Completed

NCT Number: NCT04748458

Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies

A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.

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Key information

Conditions

Dysplasia; Hip Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Prosthesis Survival Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy

Bologna, 40136, Italy

About this study

Congenital hip pathologies may severely alter the local anatomy of the hip, making total hip arthroplasty (THA) due to osteoarthritis after congenital hip pathologies challenging. While it seems that congenital hip pathologies did not significantly influence the outcomes when compared to THA after osteoarthritis, the choice of implant was demonstrated to impact the survival rates of the THA after congenital hip pathologies.

To date, no guidelines exist about the correct choice of hip implant in congenital hip pathologies: only mid-term case series are available. Conical tapered stems have been frequently suggested for the most difficult cases.

The aim of this study is to describe the survival rates and the long-term clinical and radiological outcome of conical tapered stems in THAs after congenital hip pathologies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic hip osteoarthritis due to congenital hip pathologies
  • Consecutive population with a minimum follow-up of 2 years
  • Cementless total hip arthroplasty with conical tapered stem
  • Pre-operative planning using CT
  • Complete clinical and radiographic assessment

Exclusion criteria

  • Other type of hip osteoarthritis
  • Other type of implants
  • Inadequate pre-operative planning (eg: no CT)
  • Incomplete clinical and radiographic assessment

Treatment and study plan

Conical tapered stem

Device

Implantation of conical tapered stem

Primary outcomes

  1. Harris Hip Score

    Time frame: 15 months

    Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.

  2. Survival Rate

    Time frame: 15 months

    Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.

  3. Radiographic Cup Osseointegration

    Time frame: 15 months

    Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).

  4. Radiographic Stem Osseointegration

    Time frame: 15 months

    Osseointegrated stems described according to Engh's criteria

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Retrospective Study About the Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty for Osteoarthritis Due to Congenital Hip Pathologies

Acronym: RetroCone

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
Mar 22, 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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