Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty

Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty: A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.

Study Overview

• Status: Completed
• Conditions: Inflammatory Arthritis; Osteoarthritis, Hip; Avascular Necrosis of Hip; Post-Traumatic Osteoarthritis of Hip

Detailed Description

The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.

This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System.

A total of 200 patients will be enrolled in this study that will last 12 years (2 year enrollment plus 10 years follow-up) with the following visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Kremmen, Germany, 16766
    • Sana Kliniken Sommerfeld
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg A.ö.R.
  • Viersen, Germany, 41749
    • LVR-Klinik für Orthopädie
• Sweden
  • Lund, Sweden, 221 85
    • Skåne University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

The study population will be comprised of 200 males and females who require primary total hip arthroplasty. Subjects will be enrolled at 4 investigative centers. Subjects must be geographically accessible throughout the study and be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will be offered informed consent, and eligibility will be determined based upon the inclusion/exclusion criteria.

Description

Inclusion Criteria:

• Patient is 18 to 75 years of age, inclusive.
• 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 (i.e. Rheumatoid 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 vascular (large and small vessel disease) insufficiency.
• The patient has a neurologic condition in the ipsalateral or contralateral limb which affects lower limb function.
• The patient has a diagnosed 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 has received an investigational drug or device within the previous 6 months.
• 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. 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 Index (BMI) > 40.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients who received the Allofit IT with BIOLOX delta; Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method	10 years post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety based on eventual complications occurred including dislocations and revisions/removals		10 years post-surgery
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc		10 years post-surgery
"Harris Hip Score" is a SINGLE form to measure the functional outcome of the patient.	The Harris Hip Score is a questionnaire filled by the surgeon with the patient who received a hip implant. The domains covered are: pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). Patients select a discrete set of answers which correspond to predefined point allocations based on the category. To obtain a final score, these values are summed. The scale then ranges as Excellent: 90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: < 70.	10 years post-surgery
"EQ-5D" is a SINGLE form to measure the quality-of-life of the patient.	The EQ-5D measures 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions.	10 years post-surgery
Subject quality-of-life determined by the SF-12 score	The SF-12 is a 12-item questionnaire in accordance with the "quality of life" questioning standards of the American Academy of Orthopaedic Surgeons (AAOS) Committee for Outcomes Research. The questions determine the patient's physical, emotional and social health and will be used to calculate a physical and mental functional score. This form is completed by the patient.	10 years post-surgery

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Total hip arthroplasty; Medical Device; Hip prosthesis
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Necrosis; Osteoarthritis, Hip
• Other Study ID Numbers: CME2010-24H

Drug and device information, study documents

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