Back to resultsAllofit® IT With HXPE in Total Hip Arthroplasty
Primary Purpose
Avascular Necrosis, Osteoarthritis, Hip, Inflammatory Arthritis
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RSA
Sponsored by
About this trial
This is an interventional treatment trial for Avascular Necrosis focused on measuring Total hip arthroplasty, Medical Device, Safety, Hip prosthesis
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 (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.
Sites / Locations
- Medizinische Universität Wien, Universitätsklinik für Orhopädie
- Service Clinique Chirurgicale Orthopédique et Traumatologique de l'hôpital "Hotel-Dieu"
- Klinik Vincentium
- Kliniken Dr. Erler
- Traumatoloy and Orthopaedic Surgery, Complejo Hospitalario Universitario de Santiago de Compostela
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Full cohort
Subgroup RSA
Arm Description
Prospective non Controlled to Document long term performance of Allofit IT Shell in combination with the Longevity® Liner when used in primary total hip arthroplasty.
Roentgen Stereometric Analysis (RSA) is a very accurate measurement technique used to obtain micromotion of the implants relative to bone, by means of inserted tantalum markers in the surrounding acetabulum and femur. RSA provides data on the in-vivo stability of the Cup System within 2 years and will only be conducted on 40 patients.
Outcomes
Primary Outcome Measures
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Secondary Outcome Measures
"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.
"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.
Subject quality-of-life determined by the Oxford Hip Score
The Oxford Hip Score (form 17) consists of 12 questions specific to the hip and is a patient completed form
Score 0 to 19 May indicate severe hip arthritis. It is highly likely that you may well require some form of surgical intervention, contact your family physician for a consult with an Orthopaedic Surgeon.
Score 20 to 29 May indicate moderate to severe hip arthritis. See your family physician for an assessment and x-ray. Consider a consult with an Orthopaedic Surgeon.
Score 30 to 39 May indicate mild to moderate hip arthritis. Consider seeing you family physician for an assessment and possible x-ray. You may benefit from non-surgical treatment, such as exercise, weight loss, and /or anti-inflammatory medication
Score 40 to 48 May indicate satisfactory joint function. May not require any formal treatment.
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
Safety based on eventual complications occurred including dislocations and revisions/removals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03672929
Brief Title
Allofit® IT With HXPE in Total Hip Arthroplasty
Official Title
Allofit® IT With HXPE in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2011 (Actual)
Primary Completion Date
June 5, 2024 (Anticipated)
Study Completion Date
June 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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). In addition, tantalum markers (Industrial Techtonics, Ann Arbour, Michigan, USA) for RSA will be installed into the acetabular and femoral bone of 40 patients around the implant during the surgery. Stability and motion of the Cup System will be assessed by RSA at immediate postoperative evaluation and at 4 further follow-up dates (3 months, 6 months,
1 year and 2 years postoperative).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avascular Necrosis, Osteoarthritis, Hip, Inflammatory Arthritis, Post-Traumatic Osteoarthritis of Hip
Keywords
Total hip arthroplasty, Medical Device, Safety, Hip prosthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full cohort
Arm Type
No Intervention
Arm Description
Prospective non Controlled to Document long term performance of Allofit IT Shell in combination with the Longevity® Liner when used in primary total hip arthroplasty.
Arm Title
Subgroup RSA
Arm Type
Other
Arm Description
Roentgen Stereometric Analysis (RSA) is a very accurate measurement technique used to obtain micromotion of the implants relative to bone, by means of inserted tantalum markers in the surrounding acetabulum and femur. RSA provides data on the in-vivo stability of the Cup System within 2 years and will only be conducted on 40 patients.
Intervention Type
Device
Intervention Name(s)
RSA
Intervention Description
Roentgen Stereometric Analysis (RSA) is a very accurate measurement technique used to obtain micromotion of the implants relative to bone, by means of inserted tantalum markers in the surrounding acetabulum and femur. RSA provides data on the in-vivo stability of the Cup System within 2 years.
Primary Outcome Measure Information:
Title
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time Frame
10 years post-surgery
Secondary Outcome Measure Information:
Title
"Harris Hip Score" is a SINGLE form to measure the functional outcome of the patient.
Description
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.
Time Frame
10 years post-surgery
Title
"EQ-5D" is a SINGLE form to measure the quality-of-life of the patient.
Description
The EQ-5D measures 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions.
Time Frame
10 years post-surgery
Title
Subject quality-of-life determined by the Oxford Hip Score
Description
The Oxford Hip Score (form 17) consists of 12 questions specific to the hip and is a patient completed form
Score 0 to 19 May indicate severe hip arthritis. It is highly likely that you may well require some form of surgical intervention, contact your family physician for a consult with an Orthopaedic Surgeon.
Score 20 to 29 May indicate moderate to severe hip arthritis. See your family physician for an assessment and x-ray. Consider a consult with an Orthopaedic Surgeon.
Score 30 to 39 May indicate mild to moderate hip arthritis. Consider seeing you family physician for an assessment and possible x-ray. You may benefit from non-surgical treatment, such as exercise, weight loss, and /or anti-inflammatory medication
Score 40 to 48 May indicate satisfactory joint function. May not require any formal treatment.
Time Frame
10 years post-surgery
Title
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
Time Frame
10 years post-surgery
Title
Safety based on eventual complications occurred including dislocations and revisions/removals
Time Frame
10 years post-surgery
Other Pre-specified Outcome Measures:
Title
Implant stability by Roentgen Stereometric Analysis (RSA)
Description
Roentgen Stereometric Analysis (RSA) is a very accurate measurement technique used to obtain micromotion of the implants relative to bone, by means of inserted tantalum markers in the surrounding acetabulum and femur. RSA provides data on the in-vivo stability of the Cup System within 2 years. The RSA Evaluation is completed by the Investigator or its designee upon review of the protocol required RSA images.
Time Frame
2 years post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola Vivoda
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Medizinische Universität Wien, Universitätsklinik für Orhopädie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Service Clinique Chirurgicale Orthopédique et Traumatologique de l'hôpital "Hotel-Dieu"
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Klinik Vincentium
City
Augsburg
ZIP/Postal Code
86199
Country
Germany
Facility Name
Kliniken Dr. Erler
City
Nürnberg
ZIP/Postal Code
90429
Country
Germany
Facility Name
Traumatoloy and Orthopaedic Surgery, Complejo Hospitalario Universitario de Santiago de Compostela
City
Santiago De Compostela
ZIP/Postal Code
15776
Country
Spain
12. IPD Sharing Statement
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Allofit® IT With HXPE in Total Hip Arthroplasty
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