Clinical trial NCT03672370: PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty
Official title: Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip Arthroplasty A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Avascular Necrosis
Osteoarthritis
Inflammatory Arthritis
Posttraumatic Arthritis
Keywords: Total hip arthroplasty
Medical device
Performance
Safety
Hip prosthesis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility 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.

Primary outcomes:
measure: Clinical Success Will be Based on the Harris Hip Scoring System
timeFrame: 3 years
measure: Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate
timeFrame: 4 years
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: 3 years
measure: EQ-5D
timeFrame: 3 years
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Herz-Jesu Krankenhaus
city: Wien
country: Austria
facility: Orthopädisches Spital Speising GmbH
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: