Importance of Restoring Biomechanical Correct Hip Anatomy During Total Hip Arthroplasty

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: GF hip guide; Device: ABG II modular femoral component; Procedure: Stryker Navigation System

Detailed 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?

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Department of Orthopedics, Skåne University Hospital, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: instrumented hip guide technique; A mechanical device used to measure and decide how the hip prosthesis (ABG II modular) should be implanted	Procedure: GF hip guide; Using GF hip guide to measure and control the peroperative positioning of the hip stem; Other Names: Instrument designed by the investigators; 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.; Other Names: ABG™II modular Cementless Hip System
No Intervention: conventional measuring technique; Standard way of implanting the prosthesis (ABG II standard) without special measuring device or computer navigation technique
Active Comparator: computer assisted navigation; A method to use computer navigation when positioning and sizing the hip prosthesis (ABG II modular).	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.; Other Names: ABG™II modular Cementless Hip System; Procedure: Stryker Navigation System; Using Orthomap Modular Hip Software to navigate the operation; Other Names: Stryker Orthomap Hip Navigation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Region Skane

Publications and helpful links

General Publications

• Esbjornsson AC, Kiernan S, Mattsson L, Flivik G. Geometrical restoration during total hip arthroplasty is related to change in gait pattern - a study based on computed tomography and three-dimensional gait analysis. BMC Musculoskelet Disord. 2021 Apr 20;22(1):369. doi: 10.1186/s12891-021-04226-4.
• Kiernan S, Kaptein B, Flivik C, Sundberg M, Flivik G. Unexpected varus deformity and concomitant metal ion release and MRI findings of modular-neck hip stems: descriptive RSA study in 75 hips with 8 years' follow-up. Acta Orthop. 2021 Feb;92(1):67-73. doi: 10.1080/17453674.2020.1853387. Epub 2020 Dec 10.
• Kiernan S, Geijer M, Sundberg M, Flivik G. Effect of symmetrical restoration for the migration of uncemented total hip arthroplasty: a randomized RSA study with 75 patients and 5-year follow-up. J Orthop Surg Res. 2020 Jun 17;15(1):225. doi: 10.1186/s13018-020-01736-0.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 15, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Radiostereometric Analysis (RSA); Total hip arthroplasty (THA); Hip anatomy; Hip biomechanics
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: HipBiomech-SK