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CompletedNCT02399670Updated Oct 29, 2015

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

An observational study in Coxarthrosis, sponsored by Sundsvall Hospital. Completed. Per ClinicalTrials.gov, last updated 2015-10-29.

Sponsored by Sundsvall Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
222
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Coxarthrosis

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Keywords

  • Total hip arthroplasty
  • degenerative joint disease
  • Femoral offset
  • Patient reported outcome
03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's enrollment of 222 is above the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Sundsvall Hospital is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with unilateral primary osteoarthritis (OA) treated with total hip arthroplasty were considered for inclusion operated between September 2010 and December 2013. Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were excluded.

Inclusion criteria

  • Unilateral primary osteoarthritis treated with total hip arthroplasty

Exclusion criteria

Exclusion Criteria:

  • Secondary osteoarthritis
  • Previous spinal, pelvic or lower limb injuries or fractures
  • Bilateral osteoarthritis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
222 participants (actual)
Patient registry
No

Groups and cohorts

  • Decrease femoral offset

    The FO of operated side was reduced more than 5mm compared with the contralateral side.

  • Restored femoral offset

    The FO of operated side was within 5mm restored compared with the contralateral side.

  • Increased FO

    The FO of operated side was increased more than 5mm compared with the contralateral side.

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What researchers measure

Primary outcomes

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

    Patient reported functional outcome

    Time frame: 12 months

Secondary outcomes

  1. EQ-5D

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

    Time frame: 12 months

  2. VAS scale

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

    Time frame: 12 months

  3. Hip abductor muscle strength

    and hip joint abductor muscle strength measured by electronic dynamometer.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Tezuka T, Inaba Y, Kobayashi N, Ike H, Kubota S, Kawamura M, Saito T. Effects of hip joint center location and femoral offset on abductor muscle strength after total hip arthroplasty. Mod Rheumatol. 2015 Jul;25(4):630-6. doi: 10.3109/14397595.2014.988863. Epub 2014 Dec 22. PubMed 25528862 ↗
  • Mahmood SS, Al-Amiry B, Mukka SS, Baea S, Sayed-Noor AS. Validity, reliability and reproducibility of plain radiographic measurements after total hip arthroplasty. Skeletal Radiol. 2015 Mar;44(3):345-51. doi: 10.1007/s00256-014-2055-7. Epub 2014 Nov 18. PubMed 25403426 ↗
  • Berstock JR, Hughes AM, Lindh AM, Smith EJ. A radiographic comparison of femoral offset after cemented and cementless total hip arthroplasty. Hip Int. 2014 Dec 5;24(6):582-6. doi: 10.5301/hipint.5000160. Epub 2014 Sep 1. PubMed 25198306 ↗
  • Sariali E, Klouche S, Mouttet A, Pascal-Moussellard H. The effect of femoral offset modification on gait after total hip arthroplasty. Acta Orthop. 2014 Apr;85(2):123-7. doi: 10.3109/17453674.2014.889980. Epub 2014 Feb 25. PubMed 24564749 ↗
  • Hayashi S, Nishiyama T, Fujishiro T, Hashimoto S, Kanzaki N, Nishida K, Kuroda R, Kurosaka M. Excessive femoral offset does not affect the range of motion after total hip arthroplasty. Int Orthop. 2013 Jul;37(7):1233-7. doi: 10.1007/s00264-013-1881-x. Epub 2013 Apr 5. PubMed 23553118 ↗
  • Chamnongkich S, Asayama I, Kinsey TL, Mahoney OM, Simpson KJ. Difference in hip prosthesis femoral offset affects hip abductor strength and gait characteristics during obstacle crossing. Orthop Clin North Am. 2012 Nov;43(5):e48-58. doi: 10.1016/j.ocl.2012.07.008. Epub 2012 Sep 15. PubMed 23102422 ↗
  • Cassidy KA, Noticewala MS, Macaulay W, Lee JH, Geller JA. Effect of femoral offset on pain and function after total hip arthroplasty. J Arthroplasty. 2012 Dec;27(10):1863-9. doi: 10.1016/j.arth.2012.05.001. Epub 2012 Jul 17. PubMed 22810007 ↗
  • Mahmood SS, Mukka SS, Crnalic S, Wretenberg P, Sayed-Noor AS. Association between changes in global femoral offset after total hip arthroplasty and function, quality of life, and abductor muscle strength. A prospective cohort study of 222 patients. Acta Orthop. 2016 Feb;87(1):36-41. doi: 10.3109/17453674.2015.1091955. Epub 2015 Oct 16. PubMed 26471772 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02399670
Lead sponsor
Sundsvall Hospital
Responsible party
Sponsor
First posted
Mar 26, 2015
Start date
Sep 2010
Primary completion
Dec 2013
Completion
Dec 2014
Last update
Oct 29, 2015

Study contacts

Arkan S Sayed-Noor, MD, PhD
principal investigator · Umeå University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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