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

NCT ID: NCT02399670

Last Updated: 2015-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coxarthrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Decrease femoral offset

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

No interventions assigned to this group

Restored femoral offset

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

No interventions assigned to this group

Increased FO

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sundsvall Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arkan S Sayed-Noor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UmeƄ University

References

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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.

Reference Type BACKGROUND
PMID: 25528862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25403426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25198306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24564749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23553118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23102422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22810007 (View on PubMed)

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.

Reference Type RESULT
PMID: 26471772 (View on PubMed)

Other Identifiers

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SMD_III

Identifier Type: -

Identifier Source: org_study_id

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