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Completed

NCT Number: NCT04333316

Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?

Although the success of total hip arthroplasty, many patients were dissatisfied postoperatively. Patient's reported outcome measures become of a great importance in assessment of the results after joint replacement. The aim of this prospective study is to evaluate and compare postoperative patient's satisfaction after implantation of two commonly used different designs of total hip arthroplasty.

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Key information

Conditions

Patient Satisfaction Arthritis Behavior Health Behavior Hip Osteoarthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Personal Satisfaction Rheumatic Diseases Treatment Adherence and Compliance

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The investigators conducted a prospective comparative study carried out on 180 patients suffering of hip arthritis between 2011 and 2018. They were randomized into two groups of homogenous demographic and clinical data. Group A was treated by cementless T.H.A. with a large head while group B received cementless T.H.A. with a dual mobility cup. Clinical evaluation and preoperative patient's expectation were assessed and compared to the postoperative satisfaction.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Unilateral hip arthritis
  • Age up to 65 years
  • Body mass index (BMI) up to 35
  • Modified Charnley comorbidity classification equal to A

Exclusion criteria

  • Neurological deficit (e.g. Parkinsonism, stroke)
  • Bone type c not fit for cementless fixation
  • Poly-arthritis, active inflammatory arthritis (e.g. rheumatoid arthritis)
  • Any patient with psychiatric disorders

Treatment and study plan

large head

Procedure

implantation of large head total hip

dual mobility cup

Procedure

implantation of dual mobility total hip

Primary outcomes

  1. patient's satisfaction

    Time frame: about 5 years

    measurement by patient's reported outcomes measures

  2. clinical evaluation

    Time frame: about 5 years

    WOMAC score

  3. pain assessment

    Time frame: about 5 years

    VAS score

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Principal Investigator

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2020
Registry last updated
Apr 3, 2020

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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