Allofit® IT With HXPE in Total Hip Arthroplasty

Osteoarthritis, Hip Clinical Trial

Official title:

Allofit® IT With HXPE in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03672929
• Other study ID #: CME2010-25H
• Status: Active, not recruiting
• Start date: June 5, 2011
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Austria	Medizinische Universität Wien, Universitätsklinik für Orhopädie	Wien
France	Service Clinique Chirurgicale Orthopédique et Traumatologique de l'hôpital "Hotel-Dieu"	Nantes
Germany	Klinik Vincentium	Augsburg
Germany	Kliniken Dr. Erler	Nürnberg
Spain	Traumatoloy and Orthopaedic Surgery, Complejo Hospitalario Universitario de Santiago de Compostela	Santiago De Compostela

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Austria,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of the Implant System	Survival of the implant based on removal or intended removal of any component	10 years post-surgery
Secondary	Safety of the Implant System	Safety of the system will be assessed by monitoring the frequency and incidence of adverse events.	10 years post-surgery
Secondary	Harris Hip Score	The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70	pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Secondary	EQ-5D-3L score	The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes five dimensions referring to mobility, self-care, daily activities,pain/discomfort, and anxiety/depression. Each question can be answered in three ways/levels indicating no problems, some problems, and extreme problems. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.594;negative numbers correspond to a self-assessed health state worse than being dead.	pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Secondary	EQ-5D VAS	The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her current state of health.	pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Secondary	Oxford Hip Score	The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27	pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Secondary	UCLA Activity Score	The case administered University of California at Los Angeles (UCLA) score allows assessment of the case's activity level at each time point with scores from 1 (Wholly inactive: dependent on others; cannot leave residence) to 10 (Regularly participates in impact sports)	pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Secondary	Radiographic Evaluations	X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence,heterotopic ossification, etc	pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year