Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672916
• Other study ID #: CME2010-24H
• Status: Completed
• Start date: May 2011
• Est. completion date: April 2023

Study information

• Verified date: August 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis of Hip
• Inflammatory Arthritis
• Necrosis
• Osteoarthritis
• Osteoarthritis, Hip
• Post-Traumatic Osteoarthritis of Hip

Locations

Country	Name	City	State
Germany	Sana Kliniken Sommerfeld	Kremmen
Germany	Universitätsklinikum Magdeburg A.ö.R.	Magdeburg
Germany	LVR-Klinik für Orthopädie	Viersen
Sweden	Skåne University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method		10 years post-surgery
Secondary	"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
Secondary	"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
Secondary	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
Secondary	X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc		10 years post-surgery
Secondary	Safety based on eventual complications occurred including dislocations and revisions/removals		10 years post-surgery