Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03672370
Recruitment Status : Terminated (Study terminated as CE marks of the devices used have not been renewed.)
First Posted : September 14, 2018
Results First Posted : January 14, 2021
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study.

Condition or disease
Avascular Necrosis Osteoarthritis Inflammatory Arthritis Posttraumatic Arthritis

Detailed Description:

The objectives of this study are to obtain survival and outcomes data on the Alloclassic® Variall® Cup in combination with the BIOLOX® delta Taper Liner and a BIOLOX® delta Femoral Head used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records.

Two sites are involved in this study, enrolling a total of 100 patients for the study. All subjects were required to participate in the Informed Consent Process.

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip Arthroplasty A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Actual Study Start Date : March 24, 2015
Actual Primary Completion Date : May 14, 2019
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Alloclassic® Variall® Cup
Subjects who received the Alloclassic® Variall® Cup Ceramic Bearing System



Primary Outcome Measures :
  1. Clinical Success Will be Based on the Harris Hip Scoring System [ Time Frame: 3 years ]

    The Harris Hip Score (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 points and a maximum of 100 points.

    Clinical success will be defined as a modified Harris Hip score of > 80 that included a rating of 'mild', or 'no pain'; a failure will be defined as a modified Harris Hip score < 80.


  2. Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate [ Time Frame: 4 years ]
    Endpoint revision of any investigational device for any reason attributable to any investigational device


Secondary Outcome Measures :
  1. Oxford Hip Score [ Time Frame: 3 years ]

    The purpose of the Oxford Hip Score (OHS) is to assess the outcome after total hip arthroplasty by measuring cases' perceptions in adjunction to surgery. The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc.

    The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score


  2. EQ-5D [ Time Frame: 3 years ]

    The EQ-5D questionnaire comprises two parts. For the first part, respondents are asked to tick boxes to indicate the level of problem on each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In total, there are three levels per dimension (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Responses are coded as single-digit numbers expressing the severity level selected in each dimension. The digits for the five dimensions are combined in a 5-digit code.

    The second part of the questionnaire is the EQ Visual Analogue Scale. This captures the respondent's overall assessment of their health from 0 (worst health imaginable) to 100 (best health imaginable).

    The results from both parts are indexed, weightened and pulled together. The final score lies between 1 for full health and 0 for death. Values less than 0 are possible considered to be worse than death.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in need of a primary Total Hip Arthroplasty which receive the Alloclassic® Variall® Cup in combination with a BIOLOX ® delta Taper Liner and a BIOLOX ® delta Femoral Head
Criteria

Inclusion Criteria:

  • Patient is skeletally mature.
  • Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:

    • Avascular necrosis (AVN)
    • Osteoarthritis (OA)
    • Inflammatory arthritis
    • Post-traumatic arthritis
  • Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).
  • Patient has a Harris Hip Score <70 in the affected hip
  • Patient is willing and able to provide written informed consent.
  • Patient is willing and able to cooperate in the required post-operative therapy.
  • Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
  • Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent.

Exclusion Criteria:

  • The patient is:

    • A prisoner
    • Mentally incompetent or unable to understand what participation in the study entails
    • A known alcohol or drug abuser
    • Anticipated to be non-compliant.
  • The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
  • The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
  • The patient has a known history of systemic disease that could affect his/her safety or the study outcome.
  • The patient is known to be pregnant.
  • The patient is unwilling or unable to give informed consent, or to comply with the follow-up program.
  • The patient is not having any other investigational drug or device simultaneously.
  • The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
  • The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. clinical relevant osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock.
  • The patient has osteoradionecrosis in the operative hip joint
  • The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
  • The patient has known local bone tumors in the operative hip.
  • The patient is Grade III obese with a Body Mass Inldex (BMI) > 40.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672370


Locations
Layout table for location information
Austria
Herz-Jesu Krankenhaus
Wien, Austria, 1030
Orthopädisches Spital Speising GmbH
Wien, Austria, 1130
Sponsors and Collaborators
Zimmer Biomet
Investigators
Layout table for investigator information
Study Director: Hassan Achakri Zimmer Biomet
  Study Documents (Full-Text)

Documents provided by Zimmer Biomet:
Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03672370    
Other Study ID Numbers: CME2014-03H.1
First Posted: September 14, 2018    Key Record Dates
Results First Posted: January 14, 2021
Last Update Posted: January 14, 2021
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zimmer Biomet:
Total hip arthroplasty
Medical device
Performance
Safety
Hip prosthesis
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Necrosis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes