NCT02399670

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

3.3 years

First QC Date

March 23, 2015

Last Update Submit

October 28, 2015

Conditions

Keywords

Total hip arthroplastydegenerative joint diseaseFemoral offsetPatient reported outcome

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

    Patient reported functional outcome

    12 months

Secondary Outcomes (3)

  • EQ-5D

    12 months

  • VAS scale

    12 months

  • Hip abductor muscle strength

    12 months

Study Arms (3)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Unilateral primary osteoarthritis treated with total hip arthroplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 25528862BACKGROUND
  • 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.

    PMID: 25403426BACKGROUND
  • 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.

    PMID: 25198306BACKGROUND
  • 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.

    PMID: 24564749BACKGROUND
  • 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.

    PMID: 23553118BACKGROUND
  • 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.

    PMID: 23102422BACKGROUND
  • 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.

    PMID: 22810007BACKGROUND
  • 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.

MeSH Terms

Conditions

Osteoarthritis, HipJoint Diseases

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Arkan S Sayed-Noor, MD, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

September 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

October 29, 2015

Record last verified: 2015-10