Importance of Restoring Biomechanical Correct Hip Anatomy During Total Hip Arthroplasty

NCT01512550 | Completed

• 1 other identifier: HipBiomech-SK
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Radiostereometric Analysis (RSA); Total hip arthroplasty (THA); Hip anatomy; Hip biomechanics

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (3)

• Gait analysis

  Preoperatively (3-4 weeks) and 1 year postoperatively

• Computer Tomography (CT)

  Preoperatively (3-4 weeks) and 1 year postoperatively

• General and hip specific health questionnaires

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

Study Arms (3)

instrumented hip guide technique

ACTIVE COMPARATOR

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

Procedure: GF hip guide; Device: ABG II modular femoral component

conventional measuring technique

NO INTERVENTION

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

computer assisted navigation

ACTIVE COMPARATOR

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

Procedure: Stryker Navigation System; Device: ABG II modular femoral component

Interventions

GF hip guide PROCEDURE

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

Also known as: Instrument designed by the investigators

instrumented hip guide technique

Stryker Navigation System PROCEDURE

Using Orthomap Modular Hip Software to navigate the operation

Also known as: Stryker Orthomap Hip Navigation System

computer assisted navigation

ABG II modular femoral component 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.

Also known as: ABG™II modular Cementless Hip System

computer assisted navigation; instrumented hip guide technique

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Orthopedics, Skane University Hospital, Lund University

Lund, 22185, Sweden

Location

Related Publications (3)

• 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.

  PMID: 33879123 DERIVED

• 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.

  PMID: 33297800 DERIVED

• 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.

  PMID: 32552711 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Gunnar Flivik, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD PhD

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 19, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

SE (1)