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OsteoarthritisNCT01512550

Importance of Restoring Biomechanical Correct Hip Anatomy During Total Hip Arthroplasty

A study testing GF hip guide, Stryker Navigation System and ABG II modular femoral component in people with Osteoarthritis, run by Region Skane at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Osteoarthritis
What is being tested?
GF hip guide, Stryker Navigation System and ABG II modular femoral component
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSweden
Study dates
Jan 2010to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Rheumatoid arthritis
  • Malignant disease
  • Severe osteoporosis
  • Patients with active infection
  • Patients with malignancy
  • Prior major surgery in the hip to be operated on
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Orthopedics, Skane University Hospital, Lund University

    Lund, 22185

Other trials in Sweden

About this study

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

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

Read the 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
Being tested
GF hip guide, Stryker Navigation System, ABG II modular femoral component
Keywords
Radiostereometric Analysis (RSA), Total hip arthroplasty (THA), Hip anatomy, Hip biomechanics
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GF hip guideProcedure or surgery

    Also called Instrument designed by the investigators

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

  • Stryker Navigation SystemProcedure or surgery

    Also called Stryker Orthomap Hip Navigation System

    Using Orthomap Modular Hip Software to navigate the operation

  • ABG II modular femoral componentDevice

    Also called 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.

Study groups in NCT01512550
Study groupRoleWhat they receive
instrumented hip guide techniqueActive comparatorA mechanical device used to measure and decide how the hip prosthesis (ABG II modular) should be implanted
Receives: Procedure: GF hip guide; Device: ABG II modular femoral component
conventional measuring techniqueNo interventionStandard way of implanting the prosthesis (ABG II standard) without special measuring device or computer navigation technique
computer assisted navigationActive comparatorA method to use computer navigation when positioning and sizing the hip prosthesis (ABG II modular).
Receives: Procedure: Stryker Navigation System; Device: ABG II modular femoral component

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: First postoperative day(reference examination), 14 days, 3 months, 1 and 2 years

Secondary outcomes (3)

  1. 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.

    Measured: Preoperatively (3-4 weeks) and 1 year postoperatively

  2. 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.

    Measured: Preoperatively (3-4 weeks) and 1 year postoperatively

  3. 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

    Measured: preoperatively (3-4 weeks), 1 and 2 years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2012 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2011
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01512550
Sponsor's protocol ID
HipBiomech-SK
Status last verified
Sep 2017
First submitted
6 Jan 2012
Last updated
28 Sep 2017
Results posted
No
Data monitoring committee
No

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.

    PubMed 33879123

  • 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.

    PubMed 33297800

  • 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.

    PubMed 32552711

Questions about this trial

What is this clinical trial studying?

A study testing GF hip guide, Stryker Navigation System and ABG II modular femoral component in people with Osteoarthritis, run by Region Skane at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiostereometric Analysis (RSA) (time frame: First postoperative day(reference examination), 14 days, 3 months, 1 and 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01512550, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.

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