Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatments gf hip guide, stryker navigation system, abg ii modular femoral component
Sponsor Region Skane
Start date January 2010
End date December 2011
Trial size 75 participants
Trial identifier NCT01512550, HipBiomech-SK

Summary

The purpose of this prospective, randomized study is to evaluate the importance of restoring the exact individual hip biomechanics during total hip arthroplasty.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
A mechanical device used to measure and decide how the hip prosthesis (ABG II modular) should be implanted
gf hip guide Instrument designed by the investigators
Using GF hip guide to measure and control the peroperative positioning of the hip stem
abg ii modular femoral component ABG™II modular Cementless Hip System
A hip prosthesis made by Stryker. It has the same basic shape as the ABG II femoral component but has a modular neck system allowing it to better follow the patient specific hip anatomy regarding offset, varus-valgus angle and rotation in the anteroposterior plane.
(No Intervention)
Standard way of implanting the prosthesis (ABG II standard) without special measuring device or computer navigation technique
(Active Comparator)
A method to use computer navigation when positioning and sizing the hip prosthesis (ABG II modular).
stryker navigation system Stryker Orthomap Hip Navigation System
Using Orthomap Modular Hip Software to navigate the operation
abg ii modular femoral component ABG™II modular Cementless Hip System
A hip prosthesis made by Stryker. It has the same basic shape as the ABG II femoral component but has a modular neck system allowing it to better follow the patient specific hip anatomy regarding offset, varus-valgus angle and rotation in the anteroposterior plane.

Primary Outcomes

Measure
Radiostereometric Analysis (RSA)
time frame: First postoperative day(reference examination), 14 days, 3 months, 1 and 2 years

Secondary Outcomes

Measure
Gait analysis
time frame: Preoperatively (3-4 weeks) and 1 year postoperatively
Computer Tomography (CT)
time frame: Preoperatively (3-4 weeks) and 1 year postoperatively
General and hip specific health questionnaires
time frame: preoperatively (3-4 weeks), 1 and 2 years postoperatively

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

Inclusion Criteria: - Osteoarthritis (OA) of the hip necessitating primary total hip arthroplasty (THA) - Male and non-pregnant female patients - Hip bone quality and morphology suitable for uncemented THA - Age up to 75 years old at the inclusion time of the study - Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up. - Patients who are capable of, and have given informed consent for participation in the study. Exclusion Criteria: - Rheumatoid arthritis - Malignant disease - Severe osteoporosis - Patients with active infection - Patients with malignancy - Prior major surgery in the hip to be operated on - Peroperative fracture - Hip prosthesis or grossly distorted hip anatomy in the contralateral hip. - Ongoing corticosteroid (oral) or immunosuppressive medication - Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain. - Patients with concurrent illnesses which are likely to affect their outcome.

Additional Information

Official title Evaluation of the Importance in Restoring Biomechanical Correct Hip Anatomy During THA. A Prospective, Randomized and Controlled Study Evaluated by RSA, CT and Gait Analysis
Principal investigator Gunnar Flivik, MD PhD
Description This prospective, controlled and randomized study aims at evaluating the correlation between postoperative hip prosthesis migration and the achieved exactness of biomechanical restoration of hip mechanics during total hip arthroplasty (THA). The main objective is to find out how close the result from the surgery can come to a preferred prosthesis position and whether this makes any difference in terms of loosening, functionality and quality of life for the patient. The prosthesis positioning is performed with either (1) computer assisted navigation, (2) instrumented hip guide measuring devise alignment technique or (3) conventional non-instrumented measuring technique. The ABG II stem system (Stryker) will be used in the modular version for group 1 and 2 and the non-modular version in group 3. Before each operation the investigators will perform exact measurements of anatomical variables using preoperative radiographs (maximum 8 weeks old) and computed tomography images (CT)(taken 3-4 weeks preoperatively). While applying these measurements the investigators will try to preserve the patient´s individual biomechanical situation, most often as compared to the healthy contralateral hip. The variables to be analysed are anteversion of the femoral neck, offset and leg length. This preoperative hip analysis combined with the use of a templating system will give the data needed for component choice and exact positioning of the ABG II hip prosthesis. 75 patients will be randomized into the three groups (25+25+25). The patients will be followed with RadioStereometric Analysis (RSA) for two years (directly postoperatively, 14 days, 3 months, 1 year and 2 years). There will be a second CT scan 1 year postoperatively to measure the actual achieved position. In completion hip specific and general health questionnaires will be used to evaluate patient satisfaction and outcome. All patients will be subject to 3-Dimensional (3-D) gait analysis 3-4 weeks prior to surgery and after one year. The results of the gait analysis will be correlated to the achieved restoration of the hip anatomy and biomechanics. The investigators aim is to improve the fundamental understanding of the hip biomechanics in patients undergoing THA. Will physical performance improve when the individual hip biomechanics is better restored, and in which way and to what extent?
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Region Skane.