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Completed

NCT Number: NCT03657953

Outcomes 8 Years After Minimal Invasive THA

There exists only limited scientific evidence concerning medium- to long-term benefits concerning minimally invasive (MI) total hip arthroplasty (THA). The investigators examined in a randomized study design 157 patients 8 years after THA, which were performed via 3 different surgical approaches.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dresden, Orthopaedic Department

Dresden, 01307, Germany

About this study

In contrast to reported short-term advantages of minimally invasive (MI) total hip arthroplasty (THA) there exists only limited scientific evidence concerning medium- to long-term benefits.

The investigators therefore sought to answer the following questions: Is the functional medium-term outcome in THA patients with MI-anterior(MI-A) and MI-anterolateral (MI-AL) approach superior to those treated by direct lateral approach (DLA)? Is the level of life quality increased by MI-THA? Is patient satisfaction higher by MI-THA? Is the revision rate reduced by MI-THA?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical and radiologic signs of advanced hip joint Degeneration
  • Patients from age 18 to 75

Exclusion criteria

  • osteoporosis and
  • osteomalacia,
  • preceding surgery or radiation therapy in the proximity of the affected hip joint,
  • progressive neoplasia,
  • preceding or manifest infection of the affected joint and its surrounding soft tissues,
  • rheumatoid arthritis,
  • hip dysplasia Hartofilakidis type 2 or 3,
  • non-compliance,
  • chronic neurological or psychiatric diseases,
  • ongoing pregnancy

Treatment and study plan

Surgical approach

Other

Primary outcomes

  1. Physical function hip - Harris-Hip-Score (HHS)

    Time frame: change from baseline (preoperative) at 8 years after THA

    Harris-Hip-Score (worst=0, best=100)

Secondary outcomes

  1. Physical function hip - WOMAC

    Time frame: change from baseline (preoperative) at 8 years after THA

    WOMAC Total Score (worst=0, best=100)

  2. Satisfaction Level

    Time frame: at 8 years after THA

    Satisfaction scale (worst=0, best=10)

  3. health related Quality of life - Index

    Time frame: change from baseline (preoperative) at 8 years after THA

    EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1)

  4. health related Quality of life - VAS

    Time frame: change from baseline (preoperative) at 8 years after THA

    EQ-Visual Analogue Scale (worst=0, best=100)

  5. Physical Activity

    Time frame: change from baseline (preoperative) at 8 years after THA

    University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)

  6. Revision rate

    Time frame: at 8 years after THA

    Revision rate using Kaplan-Meier-Survival Analysis

  7. Physical Activity Performance Test: walking

    Time frame: change from baseline (preoperative) at 8 years after THA

    25-meter walking time

  8. Physical Activity Performance Test: stair climbing

    Time frame: change from baseline (preoperative) at 8 years after THA

    5-step walking time

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Stryker Instruments

Registry information

Official study title

Patient-relevant Outcomes 8 Years After Minimally Invasive Total Hip Replacement - a Randomized Prospective Study

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2018
Registry last updated
Sep 5, 2018

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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