Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty

NCT ID: NCT02102334

Last Updated: 2014-04-02

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

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-12-31

Brief Summary

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In total hip arthroplasty (THA), radiographic preoperative planning and postoperative evaluation of acetabular component, femoral offset (FO) and leg length discrepancy (LLD) require good validity, interobserver reliability and intraobserver reproducibility.

Questions/purposes: (1) Evaluate the validity of the Sundsvall method of FO measurement by comparing it to a standard FO measurement method. (2) Evaluate the interobserver reliability and intraobserver reproducibility of measurement of FO, LLD, acetabular cup inclination and anteversion.

90 patients with primary unilateral osteoarthritis (OA) were included in this prospective study. On postoperative radiographs FO by the Sundsvall method, FO by a standard method, LLD, acetabular cup inclination and anteversion were measured. The interobserver reliability and intraobserver reproducibility were made by three independent observers. The validity and degree of prediction of Sundsvall method are measured by comparing its results with the standard method.

Detailed Description

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Conditions

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Osteoarthritis of the Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Unilateral osteoarthritis

Patients operated with a total hip replacement due to unilateral osteoarthritis of the hip. Radiographic measurements of the postoperative radiographs.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* unilateral total hip replacement with either a cemented Lubinus SP II system (Link, Germany) or an uncemented CLS stem and Triology cup (Zimmer, U.S.A).

Exclusion Criteria

* Patient with secondary (OA), previous spinal, pelvic, or lower limb injuries or fractures were excluded.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sundsvall Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lennart Bråbäck

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arkan S Sayed-Noor, MD,PhD,FRCS

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Sundsvall hostpital

Sundsvall, Västernorrland County, Sweden

Site Status

Countries

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Sweden

References

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Kjellberg M, Englund E, Sayed-Noor AS. A new radiographic method of measuring femoral offset. The Sundsvall method. Hip Int. 2009 Oct-Dec;19(4):377-81. doi: 10.1177/112070000901900413.

Reference Type BACKGROUND
PMID: 20041386 (View on PubMed)

Lecerf G, Fessy MH, Philippot R, Massin P, Giraud F, Flecher X, Girard J, Mertl P, Marchetti E, Stindel E. Femoral offset: anatomical concept, definition, assessment, implications for preoperative templating and hip arthroplasty. Orthop Traumatol Surg Res. 2009 May;95(3):210-9. doi: 10.1016/j.otsr.2009.03.010. Epub 2009 May 6.

Reference Type BACKGROUND
PMID: 19423418 (View on PubMed)

Gililland JM, Anderson LA, Boffeli SL, Pelt CE, Peters CL, Kubiak EN. A fluoroscopic grid in supine total hip arthroplasty: improving cup position, limb length, and hip offset. J Arthroplasty. 2012 Sep;27(8 Suppl):111-6. doi: 10.1016/j.arth.2012.03.027. Epub 2012 May 3.

Reference Type BACKGROUND
PMID: 22560563 (View on PubMed)

Konyves A, Bannister GC. The importance of leg length discrepancy after total hip arthroplasty. J Bone Joint Surg Br. 2005 Feb;87(2):155-7. doi: 10.1302/0301-620x.87b2.14878.

Reference Type BACKGROUND
PMID: 15736733 (View on PubMed)

Bonett DG. Sample size requirements for estimating intraclass correlations with desired precision. Stat Med. 2002 May 15;21(9):1331-5. doi: 10.1002/sim.1108.

Reference Type BACKGROUND
PMID: 12111881 (View on PubMed)

Woolson ST, Hartford JM, Sawyer A. Results of a method of leg-length equalization for patients undergoing primary total hip replacement. J Arthroplasty. 1999 Feb;14(2):159-64. doi: 10.1016/s0883-5403(99)90119-5.

Reference Type BACKGROUND
PMID: 10065720 (View on PubMed)

Wylde V, Maclean A, Blom AW. Post-operative radiographic factors and patient-reported outcome after total hip replacement. Hip Int. 2012 Mar-Apr;22(2):153-9. doi: 10.5301/HIP.2012.9225.

Reference Type BACKGROUND
PMID: 22547373 (View on PubMed)

Wylde V, Whitehouse SL, Taylor AH, Pattison GT, Bannister GC, Blom AW. Prevalence and functional impact of patient-perceived leg length discrepancy after hip replacement. Int Orthop. 2009 Aug;33(4):905-9. doi: 10.1007/s00264-008-0563-6. Epub 2008 Apr 25.

Reference Type BACKGROUND
PMID: 18437379 (View on PubMed)

Little NJ, Busch CA, Gallagher JA, Rorabeck CH, Bourne RB. Acetabular polyethylene wear and acetabular inclination and femoral offset. Clin Orthop Relat Res. 2009 Nov;467(11):2895-900. doi: 10.1007/s11999-009-0845-3. Epub 2009 May 2.

Reference Type BACKGROUND
PMID: 19412648 (View on PubMed)

Patel SR, Toms AP, Rehman JM, Wimhurst J. A reliability study of measurement tools available on standard picture archiving and communication system workstations for the evaluation of hip radiographs following arthroplasty. J Bone Joint Surg Am. 2011 Sep 21;93(18):1712-9. doi: 10.2106/JBJS.J.00709.

Reference Type BACKGROUND
PMID: 21938375 (View on PubMed)

Kjellberg M, Al-Amiry B, Englund E, Sjoden GO, Sayed-Noor AS. Measurement of leg length discrepancy after total hip arthroplasty. The reliability of a plain radiographic method compared to CT-scanogram. Skeletal Radiol. 2012 Feb;41(2):187-91. doi: 10.1007/s00256-011-1166-7. Epub 2011 Apr 14.

Reference Type BACKGROUND
PMID: 21491155 (View on PubMed)

Moskal JT, Capps SG. Acetabular component positioning in total hip arthroplasty: an evidence-based analysis. J Arthroplasty. 2011 Dec;26(8):1432-7. doi: 10.1016/j.arth.2010.11.011. Epub 2011 Feb 5.

Reference Type BACKGROUND
PMID: 21296551 (View on PubMed)

Other Identifiers

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RMVL

Identifier Type: -

Identifier Source: org_study_id

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