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

Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip Arthroplasty A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

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

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Avascular Necrosis; 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1030
    • Herz-Jesu Krankenhaus
  • Wien, Austria, 1130
    • Orthopädisches Spital Speising GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success Will be Based on the Harris Hip Scoring System	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.	3 years
Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate	Endpoint revision of any investigational device for any reason attributable to any investigational device	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Hip Score	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	3 years
EQ-5D	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.	3 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2015
• Primary Completion (Actual): May 14, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Performance; Total hip arthroplasty; Hip prosthesis; Medical device
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Necrosis
• Other Study ID Numbers: CME2014-03H.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No