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Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty

NCT ID: NCT01113762

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2019-11-30

Brief Summary

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Younger hip patients often need revision of their hip replacement due to wear and loosening. Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces in metal may reduce the wear, increase the longevity of the implant and give an improved function. The possible downside is that these concepts releases metal debris to the body. The investigators wish to see if the newer interventions are a clinical improvement compared to standard. The investigators also wish to investigate the extent of metal released to the body and any effect on the immune system. Finally the investigators wish to investigate the stability of these new implants and their ability to preserve the bone around the implant.

The investigators hypothesis is:

That the metal on metal articulations will not have better clinical outcomes than standard The resurfacing implant is expected to preserve the bone of the upper femoral bone. The implants are expected to be stabile within the first year.

Detailed Description

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Conditions

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Osteoarthritis, Hip

Keywords

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Arthroplasty, Replacement, Hip Bone Density Rehabilitation T-Lymphocytes Chromium Alloys

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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resurfacing

a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint

Group Type EXPERIMENTAL

articular surface replacement ASR, DePuy

Intervention Type DEVICE

posterolateral incision

large head THA

a standard stemmed THA but with a large metal head, and a metal-metal articulation

Group Type EXPERIMENTAL

ReCap/Magnum modular head, Biomet

Intervention Type DEVICE

posterolateral incision

28 mm ceramics-polyethylene

a standard 28 mm head uncemented THA

Group Type ACTIVE_COMPARATOR

Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet

Intervention Type DEVICE

posterolateral incision

28 mm metal-polyethylene THA

a standard stemmed uncemented THA

Group Type ACTIVE_COMPARATOR

28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)

Intervention Type DEVICE

posterolateral incision

Interventions

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articular surface replacement ASR, DePuy

posterolateral incision

Intervention Type DEVICE

ReCap/Magnum modular head, Biomet

posterolateral incision

Intervention Type DEVICE

Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet

posterolateral incision

Intervention Type DEVICE

28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)

posterolateral incision

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary hip osteoarthritis
* Secondary osteoarthritis due to mild dysplasia
* Age from 40 to 65 years

Exclusion Criteria

* Dysplasia with CE angle \< 25 degrees on the AP projection
* Severe femoral head deformation
* Reduced femoral neck length
* Leg length discrepancy more than 1 cm
* Need for restoration of offset
* Deformation after fractures or earlier osteotomies
* A previous hip arthroplasty
* Inflammatory arthritis
* Endocrinological disease with bone metabolic manifestations
* Renal disease
* Malignant disease
* Neuro/muscular or vascular diseases of the affected leg
* Osteoporosis
* Use of opioid pain killers due to other diseases
* High dose corticosteroids
* Obese with BMI \> 35
* Pregnant or planning to be
* Ppresented problems that would prevent completing our follow-up program
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of the Interior and Health, Denmark

OTHER_GOV

Sponsor Role collaborator

Region Zealand

OTHER

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

DePuy Orthopaedics

INDUSTRY

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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jeannette ostergaard penny

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soeren Overgaard, MD, professor, phd

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

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Naestved Hospital Dept. of orthop. surg.

Næstved, , Denmark

Site Status

Odense University hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Penny JO, Varmarken JE, Ovesen O, Nielsen C, Overgaard S. Metal ion levels and lymphocyte counts: ASR hip resurfacing prosthesis vs. standard THA: 2-year results from a randomized study. Acta Orthop. 2013 Apr;84(2):130-7. doi: 10.3109/17453674.2013.784657.

Reference Type DERIVED
PMID: 23597114 (View on PubMed)

Penny JO, Ovesen O, Varmarken JE, Overgaard S. Similar range of motion and function after resurfacing large-head or standard total hip arthroplasty. Acta Orthop. 2013 Jun;84(3):246-53. doi: 10.3109/17453674.2013.788435. Epub 2013 Mar 26.

Reference Type DERIVED
PMID: 23530872 (View on PubMed)

Nissen T, Douw K, Overgaard S. Patient-reported outcome of hip resurfacing arthroplasty and standard total hip replacement after short-term follow-up. Dan Med Bull. 2011 Oct;58(10):A4310.

Reference Type DERIVED
PMID: 21975150 (View on PubMed)

Other Identifiers

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VF20050133

Identifier Type: -

Identifier Source: org_study_id