Skip to main content
OpenTrials
Completed

NCT Number: NCT02399670

The Influence of Global Femoral-offset Changes After Total Hip Arthroplasty

The femoral-offset (FO) is one of the important perioperative parameters in THA. A prospective cohort study was conducted between September 2010 and December 2013. All patients with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion. Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were excluded. Global FO was measured in each patient within 3 months before the THA and at the second postoperative day using a standardized protocol. According to the postoperative measurement, patients were divided into three groups: 1) the decreased FO group, where the FO of operated side was reduced more than 5mm compared with the contralateral side, 2) the restored FO group, where the FO of operated side was within 5mm restored compared with the contralateral side, and 3) the increased FO group, where the FO of operated side was increased more than 5mm compared with the contralateral side.

Patients were followed-up at 12 - 15 months postoperatively with self-administered WOMAC and EQ-5D questionnaires in addition to a clinical assessment with palpation of the operated hip and measurement of the abductor muscle strength.

Completed

Looking for future studies?

Notify Me

Key information

About this study

The results of total hip arthroplasty (THA) have shown great improvement during the last decades in terms of function, quality of life and prosthetic survival. Beside pain relief, surgeons aim to position the stem and cup in a correct manner to restore the biomechanical forces and range of motion of the operated hip. The femoral-offset (FO) is one of the important perioperative parameters in THA. A prospective cohort study was conducted between September 2010 and December 2013. All patients with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion. Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were excluded. Global FO was measured in each patient within 3 months before the THA and at the second postoperative day using a standardized protocol. According to the postoperative measurement, patients were divided into three groups: 1) the decreased FO group, where the FO of operated side was reduced more than 5mm compared with the contralateral side, 2) the restored FO group, where the FO of operated side was within 5mm restored compared with the contralateral side, and 3) the increased FO group, where the FO of operated side was increased more than 5mm compared with the contralateral side.

Patients were followed-up at 12 - 15 months postoperatively with self-administered WOMAC and EQ-5D questionnaires in addition to a clinical assessment. Patients completed an additional questionnaire enquiring about any residual problems with the use of walking aid and residual pain around the operated hip. During the clinical assessment, palpation of the operated hip and measurement of the abductor muscle strength were undertaken.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Unilateral primary osteoarthritis treated with total hip arthroplasty

Exclusion criteria

  • Secondary osteoarthritis
  • Previous spinal, pelvic or lower limb injuries or fractures
  • Bilateral osteoarthritis

Treatment and study plan

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

    Time frame: 12 months

    Patient reported functional outcome

Secondary outcomes

  1. EQ-5D

    Time frame: 12 months

    EQ-5D that measures quality of life over 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  2. VAS scale

    Time frame: 12 months

    visual analogue scale (VAS) scale measuring pain in the operated hip during the last week-

  3. Hip abductor muscle strength

    Time frame: 12 months

    and hip joint abductor muscle strength measured by electronic dynamometer.

Sponsors and collaborators

Lead sponsor

Sundsvall Hospital

Other

Registry information

Official study title

The Influence of Global Femoral-offset Changes After Total Hip Arthroplasty on Function, Quality of Life and Abductor Muscle Strength: a Prospective Cohort Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Mar 26, 2015
Registry last updated
Oct 29, 2015

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.

Published trials that share one or more normalized conditions with this study.