Allofit® IT With HXPE in Total Hip Arthroplasty

Zimmer Biomet

Status: Completed

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

Treatments: Device: RSA

Study type: Observational

Funder types: Industry

Identifiers

NCT03672929

CME2010-25H

Details and patient eligibility

About

The study design is a multi-center, prospective, non-controlled, consecutive cohort postmarket clinical follow-up study to obtain survival and outcome data on the Allofit IT Shell in combination with Longevity Liners in primary total hip arthroplasty.

Full description

The study will involve orthopedic surgeons skilled in total hip arthroplasty and experienced with the implants subject of this study. In total, 5 centers will be involved. This number of clinical sites will permit assessment of the consistency among a multitude of Investigators. A total number of 200 subjects will be included in the study. It is anticipated that each clinical site will enroll 40-60 eligible study subjects, who have provided written informed consent.

Ethics Committee (EC) approval for each site has to be obtained prior to conducting this research. Sequentially, all eligible patients will be offered study enrollment at each center to avoid potential selection bias. All potential subjects will be required to participate in an informed consent process and sign an EC approved written informed consent prior to study enrollment. It is anticipated the enrollment period may be 12 months or longer to assure an adequate number of cases at each site. Each case enrolled will receive an Allofit IT HXPE Bearing System. The study is designed to be prospective to ensure that the study population is representative of the type of population that the device is intended to treat. The subjects included will be candidates for All subjects will undergo preoperative clinical, functional and radiographic evaluations, total hip arthroplasty, immediate post-operative evaluations and post-operative clinical, functional and radiographic evaluations at 6 months (± 1 month), 1 year (± 2 months), 2 year (± 2 months), 3 year (± 2 months), 5 year (± 2 months), 7 year (± 2 months), and 10 year (± 2 months).

Enrollment: 197 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 (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.

Trial design

197 participants in 1 patient group

Patients who received the Allofit IT with HXPE

Description:

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 Longevity HXPE Liners