Osteoarthritis, HipNCT05291130
AESCULAP® Plasmafit® Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene
An observational study of Osteoarthritis, Hip and Rheumatic Arthritis, run by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty at 1 site in Russia.
Trial summary
Objectives of this study is evaluate effectivness of AESCULAP® Plasmafit® Plasmafit Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene compare to the sane sistem without Vitamin E, and ceramic or metal femoral heads Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Osteoarthritis, Hip, Rheumatic Arthritis, Degenerative Osteoarthritis
- What is being tested?
- Plasmafit® Vitelene® Vitamin E
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2020to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who need total knee replacmet surgury with a diagnosis * Pertrochanteric fracture * Disorder of continuity of tibia bone * Osteoarthritis of hip * Polyosteoarthritis * Acquired deformity of musculoskeletal system * Ankylosis of joint * Rheumatoid arthritis
Who may be able to join
- All patients who needs total knee replacement surgery
- Informed consent from the patients.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Center for Traumatology, Orthopedics and Endoprosthetics
Cheboksary, Chuvashskaya Respublika, 429500
About this study
Official title: Evaluation Effectiveness of the Aesculap® Plasmafit Cementless Acetabular System in Combination With Vitelene® Polyethylene and Vitamin E Insert for Hip Arthroplasty
Objectives of this study is evaluate effectivness of AESCULAP® Plasmafit® Plasmafit Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene compare to the sane sistem without Vitamin E, and ceramic or metal femoral heads
Read the detailed description
Osteoarthritis is one most common disease in aged population, that most advanced stage needs surgical treatment. Surgical treatment usually include installation of implants. Every year new types of implants were fabricated from the new material. The effectiveness of this new devices need carefully independent assess in clinic.
- Being tested
- Plasmafit® Vitelene® Vitamin E
- Keywords
- Osteoarthritis hip, Orthopaedic surgery, Vitamin E crosslinked polyethylene, Hip arthroplasty, Ceramic femoral heads, Metal femoral heads
- Medical subject headings
- Osteoarthritis, Hip, Rheumatic Fever, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmafit® Vitelene® Vitamin EDevice
Also called Plasmafit® Acetabular Cup System, BIOLOX delta Ceramic Femoral Head, ISODUR® Metal Femoral Heads
Plasmafit® Acetabular Cup System with an insert Aesculap ® Vitelene ® Vitamin E Stabilized Highly Crosslinked Polyethylene and BIOLOX delta Ceramic Femoral Head or ISODUR® Metal Femoral Heads
| Study group | Role | What they receive |
|---|---|---|
| Plasmafit® Vitelene® Vitamin E ceramic femoral heads | Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and bioceramic femoral heads Receives: Device: Plasmafit® Vitelene® Vitamin E | |
| Plasmafit® Vitelene® Vitamin E metal femoral heads | Plasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and metal femoral heads Receives: Device: Plasmafit® Vitelene® Vitamin E | |
| Plasmafit® polyethylene metal femoral heads | Plasmafit® Acetabular Cup System with polyethylene and metal femoral heads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional assessments of hip joint replacement over time with Harris Hip Score (HHS)
The HHS is a measure of dysfunction of the hip joint. Consist of 10 items in 3 sections. Score <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: 3 year follow-up
Functional assessments of knee joint replacement over time with Knee Society Score (KSS)
The KSS is a measure of dysfunction of the knee joint. The KSS has a two sections: "Knee Score" section (7 items) and a "Functional Score" section (3 items). Results can be interpreted with the following: 80-100 = excellent; score 70-79 = good; score 60-69 = fair; score <60 = poor.
Measured: 3 year follow-up
Forgotten Joint Score-12 (FJS-12) for knee joint, modified Rankin scale
FJS-12 shows how much did the patient forget their artificial joint. Consists of 12 items, each item is answered within a 5-point Likert scale, as follows: 0: never (0 p); almost never (1 p); seldom (2 p); sometimes (3 p); and mostly (4 p). The initial raw data were converted to a scale ranging from 0 to 100 (worst to best).
Measured: 3 year follow-up
Measuring postoperative pain using the visual analog scale for pain (VAS-P)
To measure pain intensity after surgery the patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain).
Measured: 3 year follow-up
The modified Rankin scale (mRS)
mRS was used scale for measuring the degree of disability or dependence in the daily activities after joint replacement, with the following response options: 0: No symptoms at all; 1: No significant disability despite symptoms; able to carry out all usual duties and activities; 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate disability; requiring some help, but able to walk without assistance; 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6: Dead
Measured: 3 year follow-up
Secondary outcomes (5)
The assessment of the assessment of quality of life
The assessment of quality of life using EQ-5D measure: mobility, self-care, usual activities, pain/discomfort and anxiety/depression based on a three-level version included "no problems, slight problems, moderate problems, severe problems, and unable to do/extreme".
Measured: 3 year follow-up
Rentgenological assessments knee and hip replacement over time
Rentgenological results based on standing anteroposterior pelvic radiograph with assesment version, acetabular interclination, depth, height, stability of endoprosthesis components, signs of wear on the insert, presence of osteolysis zones. Installing additional locking screws, acetabular cup anteversion and inclination, limb length discrepancy after surgery.
Measured: 3 year follow-up
Postoperative complications
Period of occurrence and type of complications are recorded
Measured: 3 year follow-up
Revision surgery
The incidence of revision, time interval and types of incidence - one or two steps
Measured: 1 year follow-up
The quality-adjusted life-year
Measure of the value of health outcomes with using the Short Form 36 (SF-36) health survey
Measured: 3 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Aug 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolai U Nikolaev, MD PhD, Study chair, Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291130
- Sponsor's protocol ID
- 2020-3
- Status last verified
- Mar 2022
- First submitted
- 15 Dec 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Effectiveness of the Aesculap® Plasmafit Cementless Acetabular System in Combination With Vitelene® Polyethylene and Vitamin E Insert for Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05291130
- Acronym / sponsor ID
- 2020-3
- Keywords
- Osteoarthritis hip, Orthopaedic surgery, Vitamin E crosslinked polyethylene, Hip arthroplasty, Ceramic femoral heads, Metal femoral heads
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and ArthroplastyUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives of this study is evaluate effectivness of AESCULAP® Plasmafit® Plasmafit Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene compare to the sane sistem without Vitamin E, and ceramic or metal femoral heads
Detailed description
Osteoarthritis is one most common disease in aged population, that most advanced stage needs surgical treatment. Surgical treatment usually include installation of implants. Every year new types of implants were fabricated from the new material. The effectiveness of this new devices need carefully independent assess in clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plasmafit® Vitelene® Vitamin E ceramic femoral heads | – | Device: Plasmafit® Vitelene® Vitamin EPlasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and bioceramic femoral heads |
| Plasmafit® Vitelene® Vitamin E metal femoral heads | – | Device: Plasmafit® Vitelene® Vitamin EPlasmafit® Acetabular Cup System with Vitelene® is a highly crosslinked polyethylene stabilized with vitamin E and metal femoral heads |
| Plasmafit® polyethylene metal femoral heads | – | –Plasmafit® Acetabular Cup System with polyethylene and metal femoral heads |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who need total knee replacmet surgury with a diagnosis * Pertrochanteric fracture * Disorder of continuity of tibia bone * Osteoarthritis of hip * Polyosteoarthritis * Acquired deformity of musculoskeletal system * Ankylosis of joint * Rheumatoid arthritis
Key inclusion criteria (2 listed)
- All patients who needs total knee replacement surgery
- Informed consent from the patients.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmafit® Vitelene® Vitamin EAlso: Plasmafit® Acetabular Cup System, BIOLOX delta Ceramic Femoral Head, ISODUR® Metal Femoral HeadsPlasmafit® Acetabular Cup System with an insert Aesculap ® Vitelene ® Vitamin E Stabilized Highly Crosslinked Polyethylene and BIOLOX delta Ceramic Femoral Head or ISODUR® Metal Femoral Heads | Device | Plasmafit® Vitelene® Vitamin E ceramic femoral heads, Plasmafit® Vitelene® Vitamin E metal femoral heads |
Primary outcome
Functional assessments of hip joint replacement over time with Harris Hip Score (HHS)
Time frame: 3 year follow-up
The HHS is a measure of dysfunction of the hip joint. Consist of 10 items in 3 sections. Score <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Functional assessments of knee joint replacement over time with Knee Society Score (KSS)
Time frame: 3 year follow-up
The KSS is a measure of dysfunction of the knee joint. The KSS has a two sections: "Knee Score" section (7 items) and a "Functional Score" section (3 items). Results can be interpreted with the following: 80-100 = excellent; score 70-79 = good; score 60-69 = fair; score <60 = poor.
Forgotten Joint Score-12 (FJS-12) for knee joint, modified Rankin scale
Time frame: 3 year follow-up
FJS-12 shows how much did the patient forget their artificial joint. Consists of 12 items, each item is answered within a 5-point Likert scale, as follows: 0: never (0 p); almost never (1 p); seldom (2 p); sometimes (3 p); and mostly (4 p). The initial raw data were converted to a scale ranging from 0 to 100 (worst to best).
Measuring postoperative pain using the visual analog scale for pain (VAS-P)
Time frame: 3 year follow-up
To measure pain intensity after surgery the patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain).
The modified Rankin scale (mRS)
Time frame: 3 year follow-up
mRS was used scale for measuring the degree of disability or dependence in the daily activities after joint replacement, with the following response options: 0: No symptoms at all; 1: No significant disability despite symptoms; able to carry out all usual duties and activities; 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate disability; requiring some help, but able to walk without assistance; 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6: Dead
5 secondary outcomes
The assessment of the assessment of quality of life
Time frame: 3 year follow-up
Rentgenological assessments knee and hip replacement over time
Time frame: 3 year follow-up
Postoperative complications
Time frame: 3 year follow-up
Revision surgery
Time frame: 1 year follow-up
The quality-adjusted life-year
Time frame: 3 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
Related trials for Osteoarthritis, Hip
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Hip OA
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolai U Nikolaev, MD PhD study chair
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Rheumatic Arthritis, run by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional assessments of hip joint replacement over time with Harris Hip Score (HHS) (time frame: 3 year follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.