Clinical trial NCT02093832: Does the Femoral Head Size Can Predict the Cup Size?
Official title: Does the Femoral Head Size Can Predict the Cup Size? Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Arthroplasty
Keywords: femoral head size
cup size
Total hip arthroplasty
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 83
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.

Brief summary: This study had four aims:

1. To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.
2. To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.
3. To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter
4. To suggest an additional online monitoring tool on the accuracy of the preoperative process and implant selection. We hypothesized that high accuracy rates will be found between the preoperative planned cup size and the actual implanted cup size. Furthermore, we hypothesized that strong correlations will be found between the planned and actual implanted cup size and the actual femoral head diameter size.

Detailed description: Methods This is a retrospective study , that will include patients who underwent primary cementless THA due to end-stage hip osteoarthritis during 2011 and 2013 . Inclusion criteria were: Patients that underwent primary THA due to end-stage primary osteoarthritis; Males and females between 15-90 years of age.

Data collection The following data will be collected: patients' characteristic including gender, age at surgery and side of surgery; implant information including cup model, planed cup size, actual cup size, shell type and outer diameter size (mm); actual femoral head diameter size (mm); the difference between the planned cup size and the actual cup size that was used; the difference between the actual femoral head diameter size measured at the end of surgery and the cementless implanted cup outer diameter size; the difference between the actual femoral head diameter size and the planed cup size..

Eligibility criteria: Inclusion Criteria:

* Patients that underwent primary Total hip arthroplasty due to end-stage primary osteoarthritis;

Exclusion Criteria:

* Significant distortion in the femoral head.
* Previous reconstructive surgery - radial osteotomy and hip socket.

Primary outcomes:
measure: To evaluate the correlation between the planned preoperative cup size and the actual cup size that was implanted in surgery.
timeFrame: up to one year
Secondary outcomes:
measure: To examine the absolute difference between the implanted cup size diameter and the actual femoral head size diameter.
timeFrame: up to one year
Other outcomes:
measure: To examine the absolute difference between the planned cup size diameter and the actual femoral head size diameter
timeFrame: up to one year
Locations:
city: Afula
country: Israel
facility: HeEmek medical center
city: Afula
country: Israel
facility: Orthopedic department, HaEmek medical center
Study officials:
References: