Clinical trial NCT05291130: AESCULAP® Plasmafit® Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene
Official title: Evaluation Effectiveness of the Aesculap® Plasmafit Cementless Acetabular System in Combination With Vitelene® Polyethylene and Vitamin E Insert for Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Rheumatic Arthritis
Degenerative Osteoarthritis
Keywords: Osteoarthritis hip
Orthopaedic surgery
Vitamin E crosslinked polyethylene
Hip arthroplasty
Ceramic femoral heads
Metal femoral heads
Lead sponsor: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* All patients who needs total knee replacement surgery
* Informed consent from the patients.

Exclusion Criteria:

-

Primary outcomes:
measure: Functional assessments of hip joint replacement over time with Harris Hip Score (HHS)
timeFrame: 3 year follow-up
measure: Functional assessments of knee joint replacement over time with Knee Society Score (KSS)
timeFrame: 3 year follow-up
measure: Forgotten Joint Score-12 (FJS-12) for knee joint, modified Rankin scale
timeFrame: 3 year follow-up
measure: Measuring postoperative pain using the visual analog scale for pain (VAS-P)
timeFrame: 3 year follow-up
measure: The modified Rankin scale (mRS)
timeFrame: 3 year follow-up
Secondary outcomes:
measure: The assessment of the assessment of quality of life
timeFrame: 3 year follow-up
measure: Rentgenological assessments knee and hip replacement over time
timeFrame: 3 year follow-up
measure: Postoperative complications
timeFrame: 3 year follow-up
measure: Revision surgery
timeFrame: 1 year follow-up
measure: The quality-adjusted life-year
timeFrame: 3 year follow-up
Other outcomes:
Locations:
city: Cheboksary
country: Russian Federation
facility: Federal Center for Traumatology, Orthopedics and Endoprosthetics
state: Chuvashia
Study officials:
affiliation: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
name: Nikolai U Nikolaev, MD PhD
role: STUDY_CHAIR
References: