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A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem

NCT ID: NCT02851992

Last Updated: 2023-12-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2028-09-30

Brief Summary

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This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.

Detailed Description

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The objective of this prospective clinical study is to obtain multi-center, long-term (10-year) clinical data on the new GTS® femoral stem in its standard and lateralized versions as part of Post Market Surveillance requirements.

The initial study assessment period will be 12 years; 24 months recruitment and the follow-up clinical reviews for all patients will be at 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.

Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GTS cementless stem

Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)

Group Type OTHER

GTS cementless stem

Intervention Type DEVICE

Total Hip Arthroplasty

Interventions

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GTS cementless stem

Total Hip Arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary osteoarthritis or secondary coxarthritis
* Inflammation of the hip: rheumatoid arthritis, etc.
* Femoral neck fracture
* Avascular necroses of the femoral head
* Sequelae from previous operations on the hip, osteotomies, etc.
* Congenital hip dysplasia


* 18 years of age or older
* Subjects willing to return for follow-up evaluations
* Subjects who read, understood study information and provided an informed written consent (specific local regulatory requirements)

Exclusion Criteria

Absolute contraindications include:

* Local or systemic infections.
* Severe muscular, neurological or vascular deficiencies of the extremity involved
* Bone destruction or poor bone quality that is likely to affect implant stability(Paget's disease, osteoporosis, etc.)
* Concomitant disease likely to affect implant function
* Allergy to any of the components of the implant
* Patients weighing more than 110 kg


* Subjects unable to co-operate with and complete the study
* Dementia and/or inability to understand and follow instructions
* Neurological conditions affecting movement
* Patient over 18 under law supervision
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ORTHO.CR.H36

Identifier Type: -

Identifier Source: org_study_id