Coxarthrosis Clinical Trial
Official 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
Verified date | October 2015 |
Source | Sundsvall Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Swedish National Council on Medical Ethics |
Study type | Observational |
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.
Status | Completed |
Enrollment | 222 |
Est. completion date | December 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Sundsvall Hospital |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Acta Orthop. 2016 Feb;87(1):36-41. doi: 10.3109/17 — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index | Patient reported functional outcome | 12 months | No |
Secondary | EQ-5D | EQ-5D that measures quality of life over 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | 12 months | No |
Secondary | VAS scale | visual analogue scale (VAS) scale measuring pain in the operated hip during the last week- | 12 months | No |
Secondary | Hip abductor muscle strength | and hip joint abductor muscle strength measured by electronic dynamometer. | 12 months | No |
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