Importance of Restoring Biomechanical Correct Hip Anatomy During Total Hip Arthroplasty

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512550
• Other study ID #: HipBiomech-SK
• Status: Completed
• Phase: N/A
• First received: January 6, 2012
• Last updated: September 26, 2017
• Start date: January 2010
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2017
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• GF hip guide
Using GF hip guide to measure and control the peroperative positioning of the hip stem
• Stryker Navigation System
Using Orthomap Modular Hip Software to navigate the operation

Device:
• ABG II modular femoral component
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.

Locations

Country	Name	City	State
Sweden	Department of Orthopedics, Skane University Hospital, Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiostereometric Analysis (RSA)	This will measure the change in migration (translation and rotation around the x-, y- and z-axis of the hip) over time from baseline which is the direct postoperative examination and up to 2 years postoperatively. The migration pattern over a 2-year period can predict the long-term fate of the prosthesis	First postoperative day(reference examination), 14 days, 3 months, 1 and 2 years
Secondary	Gait analysis	This will measure how the patients gait pattern has changed from preoperatively when the patient had symptoms from osteoarthritis and 1 year postoperatively when everything has healed and the new hip prosthesis should have full effect on function and pain relive.	Preoperatively (3-4 weeks) and 1 year postoperatively
Secondary	Computer Tomography (CT)	This will measure how much the anatomy has changed from preoperatively to after the new hip prosthesis has been put in. Are the goals of hip anatomy restoration achieved? The main measurements will be leg length, global offset and rotation of femoral neck.	Preoperatively (3-4 weeks) and 1 year postoperatively
Secondary	General and hip specific health questionnaires	Hip disability and Osteoarthritis Outcome Score (HOOS) - this is a hip specific questionnaire that will measure how the operation has affected the patients function and pain situation over time.; EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome over time	preoperatively (3-4 weeks), 1 and 2 years postoperatively