Clinical trial NCT02102334: Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty
Official title: Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis of the Hip
Keywords: Osteoarthritis, hip,
radiograpghic measurements
femoral offset
leg length discrepancy
cup anteversion
cup inclination
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Leg Length Discrepancy
timeFrame: 1 week
measure: Femoral offset (Sundsvall method)
timeFrame: 1 week
measure: Femoral offset (standard method)
timeFrame: 1 week
measure: Cup inclination
timeFrame: 1 week
measure: Acetabular cup anteversion
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Sundsvall
country: Sweden
facility: Sundsvall hostpital
state: Västernorrland county
Study officials:
affiliation: Umeå University
name: Arkan S Sayed-Noor, MD,PhD,FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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