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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00545285
Other study ID # 2007P001955
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 15, 2007
Last updated May 2, 2017
Start date November 2007
Est. completion date May 2023

Study information

Verified date May 2017
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are two distinct aims of this study:

1. This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. The clinical outcome of E-Poly will be compared to a group of subjects receiving Arcom XL polyethylene.

2. This study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (Regenerex). The clinical outcome of this new FDA cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date May 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Subjects requiring primary total hip replacement

- Subjects with diagnosis of osteoarthritis or traumatic arthritis

- Subjects who demonstrate the ability to return for follow-up for the next 10 years

Exclusion Criteria:

- Subjects with limited life span

- Subjects with difficulty in comprehending study protocol for any reason.

- Subjects with inflammatory disease, previous infection or those requiring revision hip surgery.

- Subjects with avascular necrosis

- Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used.

- Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia

- Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity.

- Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

Study Design


Intervention

Procedure:
Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survivorship: length of time implant remains without revision Evaluated at 1,3,5,7 ,10th year over 10 years
Primary Complications and Adverse Events Evaluated at 1,3,5,7 ,10th year over 10 years
Primary Incidence of radiolucencies (acetabular component) Evaluated at 1,3,5,7 ,10th year over 10 years
Primary Patient administered Outcome Survey scores Evaluated at 1,3,5,7 ,10th year over 10 years
Primary Polyethylene wear rates from AP radiographs Evaluated at 1,3,5,7 ,10th year over 10 years
Secondary Survivorship in subcategories of infection, aseptic loosening and other 1,3,5,7,10 yr over 10 years
Secondary Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life. 1,3,5,7,10 yr over 10 years
Secondary Other outcomes that may be relevant. 1,3,5,7,10 yr over 10 years
Secondary Retrieval analysis 1,3,5,7,10 yr over 10 years
See also
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Completed NCT02162186 - Clinical and Radiographic Outcomes of the Corin Tri-Fit Total Hip Replacement
Active, not recruiting NCT02263209 - Investigation to Determine Safety of Taperloc Stems With BioGuard Coating When Used in Cementless Total Hip Arthroplasty N/A
Completed NCT02577822 - The Viability of Short Stems in Total Hip Arthroplasty N/A
Active, not recruiting NCT00551967 - Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSA N/A
Completed NCT03966573 - Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints N/A
Recruiting NCT04754087 - G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study N/A
Completed NCT00957970 - Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components Phase 4
Completed NCT00565786 - ArCom® and ArComXL® Polyethylene Data Collection
Completed NCT03428893 - Mobile Technology to Support Physical Therapy Exercise N/A
Terminated NCT02161484 - Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement N/A
Completed NCT01972594 - Pedometer Based Intervention After Total Hip Replacement-A Pilot Study N/A
Withdrawn NCT01668160 - Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis N/A
Not yet recruiting NCT01040273 - Management of Postoperative Pain After Total Hip Arthroplasty Phase 2/Phase 3
Recruiting NCT02836262 - Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty N/A
Completed NCT03341442 - A Study of Posterior Hip Precautions After Total Hip Arthroplasty N/A