The Influence of Global Femoral-offset Changes After Total Hip Arthroplasty
1 other identifier
observational
222
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 23, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedOctober 29, 2015
October 1, 2015
3.3 years
March 23, 2015
October 28, 2015
Conditions
Keywords
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
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: 25528862BACKGROUNDMahmood 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: 25403426BACKGROUNDBerstock 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: 25198306BACKGROUNDSariali 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: 24564749BACKGROUNDHayashi 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: 23553118BACKGROUNDChamnongkich 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: 23102422BACKGROUNDCassidy 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: 22810007BACKGROUNDMahmood 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.
PMID: 26471772RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arkan S Sayed-Noor, MD, PhD
Umeå University
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