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

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ClinicalTrials.gov Identifier: NCT02102334
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Lennart Bråbäck, Sundsvall Hospital

Brief Summary:

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.


Condition or disease
Osteoarthritis of the Hip

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty
Study Start Date : September 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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



Primary Outcome Measures :
  1. Leg Length Discrepancy [ Time Frame: 1 week ]
    LLD on radiographs was defined as the difference in perpendicular distance in millimetres between a line passing through the lower edge of the teardrop points to the corresponding tip of the lesser trochanter. The interobserver reliability was assessed from the measurements made by three independent observers.

  2. Femoral offset (Sundsvall method) [ Time Frame: 1 week ]
    Measurement of FO using the Sundsvall method was carried out on the AP view of the pelvis as the horizontal distance (parallel to Hilgenreiners line) between the femoral axis (a line drawn through the center of the femoral shaft) and the mid line of the pelvis, at the height of the lateral tip of the greater trochanter. The measurement was performed bilaterally to compare the femoral offset on the operated side to the non-operated hip. The interobserver reliability was assessed from the measurements made by three independent observers.

  3. Femoral offset (standard method) [ Time Frame: 1 week ]
    Measurement of FO with the standard method was carried out on AP view as the addition of the distance between the longitudinal axis of the femur to center of femoral head and the distance from the center of the femoral head to a perpendicular line passing through the medial edge of the ipsilateral teardrop point of the pelvis. The measurement was repeated bilaterally to compare the FO of the operated side to non-operated hip. The interobserver reliability was assessed from the measurements made by three independent observers.

  4. Cup inclination [ Time Frame: 1 week ]
    Cup inclination was measured on AP view as angle in degrees, between a line drawn along the angle of rim of the cup and trans-ischial line (a line drawn between the most inferior point of the ischial tuberosities). The interobserver reliability was assessed from the measurements made by three independent observers.

  5. Acetabular cup anteversion [ Time Frame: 1 week ]
    Acetabular cup anteversion was measured on lateral radiograph as the angle formed by the intersection of a line drawn across the face of acetabulum and a line perpendicular to the horizontal plane, according to the Woo and Morry method. The interobserver reliability was assessed from the measurements made by three independent observers.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
90 consecutive patients with primary unilateral osteoarthritis (OA) who underwent THA between September 2010 and June 2012 were recruited into the study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102334


Locations
Sweden
Sundsvall hostpital
Sundsvall, Västernorrland county, Sweden, 856 43
Sponsors and Collaborators
Sundsvall Hospital
Investigators
Principal Investigator: Arkan S Sayed-Noor, MD,PhD,FRCS Umeå University

Publications:

Responsible Party: Lennart Bråbäck, MD, PhD, Sundsvall Hospital
ClinicalTrials.gov Identifier: NCT02102334     History of Changes
Other Study ID Numbers: RMVL
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: March 2014

Keywords provided by Lennart Bråbäck, Sundsvall Hospital:
Osteoarthritis, hip,
radiograpghic measurements
femoral offset
leg length discrepancy
cup anteversion
cup inclination

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases