Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02102334
Other study ID # RMVL
Secondary ID
Status Completed
Phase N/A
First received March 29, 2014
Last updated March 29, 2014
Start date September 2010
Est. completion date December 2013

Study information

Verified date March 2014
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

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.


Read more »

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Sweden Sundsvall hostpital Sundsvall Västernorrland county

Sponsors (1)

Lead Sponsor Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (12)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Leg Length Discrepancy 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. 1 week No
Primary Femoral offset (Sundsvall method) 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. 1 week No
Primary Femoral offset (standard method) 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. 1 week No
Primary Cup inclination 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. 1 week No
Primary Acetabular cup anteversion 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. 1 week No
See also
  Status Clinical Trial Phase
Withdrawn NCT01312285 - Low Level Magnetic Fields for the Treatment of Osteoarthritis of the Hip Phase 2
Not yet recruiting NCT02279277 - Physical Therapy Prior to Total Knee Replacement N/A
Completed NCT01501955 - The Metaphyseal Hip Prosthesis - Total Hip N/A
Completed NCT06211465 - Cardiovascular And Metabolic Risk After Arthroplasty
Terminated NCT02299271 - Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty Phase 4
Recruiting NCT02458144 - Comparison of MIS Anterior Versus MIS Anterolateral Approach N/A
Completed NCT01807104 - Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach N/A
Terminated NCT02698865 - The MONOVISC Hip Osteoarthritis Study Phase 3
Completed NCT03382262 - Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip Phase 2
Completed NCT01795781 - Assays for and Reversal of New Anticoagulants N/A
Recruiting NCT00449228 - Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement Phase 3
Withdrawn NCT00758329 - Retrospective Data Review of ReCap Total Hip Resurfacing N/A
Active, not recruiting NCT00951145 - Medium and Long Term Outcome of Total Hip Arthroplasty Using Accolade TMZF Femoral Stem N/A
Completed NCT02230657 - A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach N/A