Importance of Restoring Biomechanical Correct Hip Anatomy During Total Hip Arthroplasty

NCT ID: NCT01512550

Last Updated: 2017-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2017-09-30

Brief Summary

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

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?

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

instrumented hip guide technique

A mechanical device used to measure and decide how the hip prosthesis (ABG II modular) should be implanted

Group Type: ACTIVE_COMPARATOR

GF hip guide

Intervention Type: PROCEDURE

Using GF hip guide to measure and control the peroperative positioning of the hip stem

ABG II modular femoral component

Intervention Type: DEVICE

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.

conventional measuring technique

Standard way of implanting the prosthesis (ABG II standard) without special measuring device or computer navigation technique

Group Type: NO_INTERVENTION

No interventions assigned to this group

computer assisted navigation

A method to use computer navigation when positioning and sizing the hip prosthesis (ABG II modular).

Group Type: ACTIVE_COMPARATOR

Stryker Navigation System

Intervention Type: PROCEDURE

Using Orthomap Modular Hip Software to navigate the operation

ABG II modular femoral component

Intervention Type: DEVICE

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.

Interventions

GF hip guide

Using GF hip guide to measure and control the peroperative positioning of the hip stem

Intervention Type: PROCEDURE

Stryker Navigation System

Using Orthomap Modular Hip Software to navigate the operation

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Other Intervention Names

Instrument designed by the investigators; Stryker Orthomap Hip Navigation System; ABG™II modular Cementless Hip System

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Gunnar Flivik

Associate Professor, MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gunnar Flivik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Orthopedics, Skane University Hospital, Lund University, Sweden

Locations

Department of Orthopedics, Skane University Hospital, Lund University

Lund, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 33879123 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33297800 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32552711 (View on PubMed)

Other Identifiers

HipBiomech-SK

Identifier Type: -

Identifier Source: org_study_id