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NCT Number: NCT03437343

Leg Length and Quality of Life After Total Hip Arthroplasty

This study used 3D reconstructions from the EOS biplanar radiographic imaging system to perform leg length measurements before and after THA (Total hip arthroplasty) on all included THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after THA and the relationships between the quality of life, estimated by the HOOS score (Hip disability and osteoarthritis outcome score), and the anatomy of the new hip in standing position.

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Key information

Conditions

Total Hip Arthroplasty Bone Diseases Bone Diseases, Developmental Leg Length Inequality Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The study was conducted in patients who underwent a total hip arthroplasty in Lariboisiere Hospital, Paris, France, during the year 2015.

This retrospective study used 3D reconstructions from the EOS biplanar radiographic imaging system (EOS imaging, Paris, France) to perform leg length measurements before and after THA on all included THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after THA. Included patients either had hip osteoarthritis or femoral head osteonecrosis. Patients were excluded if they were undergoing revision surgery, or had a contralateral THA or total knee.

The performance of the surgeons was judged using the Cumulative Sum control chart (CUSUM) method.

Our objective was to study surgeon performance, measured by their ability to restore the initial preoperative length of the operated leg or to equalize the length of the two legs, and evaluate the relationships between the quality of life, estimated by the HOOS score, and the anatomy of the new hip in standing position using the EOS imaging system.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • unilateral total hip replacement for osteoarthritis or avascular necrosis healthy contralateral hip
  • age over 18 years
  • informed consent to participate in the study
  • radiographs obtained after total hip replacement using the EOS imaging system, filled HOOS form
  • clinical follow-up of 12 months at least

Exclusion criteria

  • past history of contralateral hip replacement
  • ipsi or contralateral knee replacement
  • hip arthroplasty performed using a Kerboull cross
  • post-operative complications such as infection

Treatment and study plan

hip arthroplasty

Procedure

Primary outcomes

  1. Change in anatomic lower limb length measurements between preoperative and postoperative measurements

    Time frame: preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)

Secondary outcomes

  1. Change in flessum/recurvatum/HKS angle (hip knee shaft ) measurements, between preoperative and postoperative measurements

    Time frame: preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)

  2. HOOS score (Hip disability and osteoarthritis outcome score)

    Time frame: 24 months after surgery

    The outcome score consists of 40 items assessing 5 subscales. Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each.

    To answer the questions, standardized answer options are given with scores from 0 to 4 (no, mild, moderate, severe and extreme).

    To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.

    To calculate the total HOOS score the subscales need to be summed up, using following formula for all dimension.

    100 - [(patient's score of the subscale x 100)/(total score of the subscale)]

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Région Ile de France, France

Registry information

Official study title

Evaluation of Surgeon Performance to Restore Leg Length and Evaluation of the Quality of Life After Total Hip Replacement Related to the Reconstructed Anatomy With EOS Imaging System

Acronym: EOS-PTH

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2018
Registry last updated
Feb 19, 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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