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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399670
• Other study ID #: SMD_III
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: October 28, 2015
• Start date: September 2010
• Est. completion date: December 2014

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

References & Publications (8)

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

Outcome

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