Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02247661
Other study ID # SM_II
Secondary ID
Status Completed
Phase N/A
First received September 20, 2014
Last updated October 13, 2015
Start date February 2012
Est. completion date May 2015

Study information

Verified date October 2015
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

A prospective cohort study to compare the direct lateral and poster-lateral approach concerning abductor function. Patients admitted with a femoral neck fracture operated with a hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for inclusion. Patients with altered mental status SPMSQ >7, pathological fractures, non-walkers were excluded.

Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1 year postoperatively by clinical examination. Sample size were estimated to 30 patient in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry, trochanteric tenderness measured with algometry and palptation.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date May 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility Inclusion Criteria:

- Displaced femoral neck fracture

- Walker

- Hemarthroplasty

- Preiffer test >7/10

Exclusion Criteria:

- Pathological fracture

- Non-walker

- Pfeiffer test <7/10 indicating mental alteration.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Sweden Orthopaedic department, Sundsvall hospital Sundsvall Västernorrlands län

Sponsors (1)

Lead Sponsor Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Kiyama T, Naito M, Shinoda T, Maeyama A. Hip abductor strengths after total hip arthroplasty via the lateral and posterolateral approaches. J Arthroplasty. 2010 Jan;25(1):76-80. doi: 10.1016/j.arth.2008.11.001. Epub 2009 Apr 8. — View Citation

Pai VS. Significance of the Trendelenburg test in total hip arthroplasty. Influence of lateral approaches. J Arthroplasty. 1996 Feb;11(2):174-9. — View Citation

Sköldenberg O, Ekman A, Salemyr M, Bodén H. Reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach. Acta Orthop. 2010 Oct;81(5):583-7. doi: 10.3109/17453674.2010.519170. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Trendelenburg Test 30 seconds standing on the operated leg 1 year No
Secondary Abductor strenght Dynamometry 1 year No
Secondary Trochanteric tenderness Algometry 1 year No
Secondary Trochanteric tenderness Palptation 1 year No
See also
  Status Clinical Trial Phase
Completed NCT02422355 - A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures
Withdrawn NCT02202122 - Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures N/A
Terminated NCT01219062 - Postoperative Pain Control After Hip Hemiarthroplasty: Intrathecal Morphine vs Periarticular Infiltration of Bupivacaine Phase 4
Active, not recruiting NCT02362971 - External Validity of a Randomized Trial in Patients With a Femoral Neck Fracture N/A
Completed NCT02591342 - Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture N/A
Recruiting NCT05171140 - Influence of the Spatial Distribution of Hollow Screws on the Blood Supply and Prognosis of Femoral Neck Fractures N/A
Completed NCT02433548 - Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture Phase 4
Active, not recruiting NCT03357445 - AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study N/A
Recruiting NCT03550079 - Fixation for the Treatment of Femoral Neck Fractures N/A
Completed NCT04879472 - Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres
Completed NCT00913679 - A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty N/A
Recruiting NCT02877472 - Porous Tantalum Rods Improve the Hip Joint Function of Patients With Avascular Necrosis of the Femoral Head N/A
Recruiting NCT01112436 - The Effect of Periarticular Multi-Drug Regimen on Pain After Partial Hip Replacement Phase 4
Completed NCT01052974 - Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol Phase 4
Terminated NCT02030431 - Dynaloc for Treatment of Femoral Neck Fractures N/A
Completed NCT01114646 - Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty N/A
Completed NCT02512094 - Validity and Reliability of Thai Version of Barthel Index for Hip Fracture Patients N/A
Recruiting NCT02148848 - Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty Phase 4
Completed NCT01644227 - Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk N/A
Active, not recruiting NCT02901938 - Feasibility of Implantation of Cemented Femoral Stem for Osteoporotic Femoral Neck Fracture in Elderly Patients N/A