Importance of Restoring Biomechanical Correct Hip Anatomy During Total Hip Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gunnar Flivik, Region Skane
ClinicalTrials.gov Identifier:
NCT01512550
First received: January 6, 2012
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Osteoarthritis
Procedure: GF hip guide
Procedure: Stryker Navigation System
Device: ABG II modular femoral component

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Radiostereometric Analysis (RSA) [ Time Frame: First postoperative day(reference examination), 14 days, 3 months, 1 and 2 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Gait analysis [ Time Frame: Preoperatively (3-4 weeks) and 1 year postoperatively ] [ Designated as safety issue: No ]
    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.

  • Computer Tomography (CT) [ Time Frame: Preoperatively (3-4 weeks) and 1 year postoperatively ] [ Designated as safety issue: No ]
    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.

  • General and hip specific health questionnaires [ Time Frame: preoperatively (3-4 weeks), 1 and 2 years postoperatively ] [ Designated as safety issue: No ]

    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



Enrollment: 75
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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).
Procedure: Stryker Navigation System
Using Orthomap Modular Hip Software to navigate the operation
Other Name: Stryker Orthomap Hip Navigation System
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 Name: ABG™II modular Cementless Hip 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?

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512550

Locations
Sweden
Department of Orthopedics, Skane University Hospital, Lund University
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Gunnar Flivik, MD PhD Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
  More Information

No publications provided

Responsible Party: Gunnar Flivik, Associate Professor, MD PhD, Region Skane
ClinicalTrials.gov Identifier: NCT01512550     History of Changes
Other Study ID Numbers: HipBiomech-SK
Study First Received: January 6, 2012
Last Updated: July 5, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Radiostereometric Analysis (RSA)
Total hip arthroplasty (THA)
Hip anatomy
Hip biomechanics

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014