Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
- Conditions
- Osteoarthritis, Hip
- Registration Number
- NCT05773261
- Lead Sponsor
- Umeå University
- Brief Summary
A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.
- Detailed Description
The purpose of this study is to evaluate the clinical outcome and long-term risk of development of osteolysis of a newly introduced cementless press-fit acetabular cup, consisting of a shell with a 3D surface structure and a highly cross-linked liner by precise measurement of early migration and wear.
Migration describes the movement between the implant and the surrounding bone over time. Early migration of the implant, within 2 years after operation, has shown to be a strong predictor for increased risk for late failure. Thus, high precision migration studies can be used to evaluate the performance of new implants in small groups of patients with a relatively short observation time. Wear particles are one of the main causes of periprosthetic osteolysis. Although modern, more wear resistant materials, appears to have a greatly reduced risk of osteolysis, the desired complete elimination of osteolysis appears to be yet unachieved. It is most likely that the mechanism of periprosthetic osteolysis is multifactorial.
In this study the investigators plan to include 70 patients that are planned for operation with an uncemented total hip arthroplasty. 35 patients will be randomized to receive the new implant and 35 patients will be included in the control group and receive a standard uncemented prosthesis. All patients will then be followed with CT scans and patient reported outcome measures 3-month, 1 year, 2 years, 5 years and 15 years after the operations. The CT scans will be used both for measurement of migration and wear and development of osteolysis around the implant.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- Patients are foreseen for implantation of an uncemented acetabular press-fit cup and an uncemented stem
- Age 30-70 years
- Primary osteoarthritis of the hip
- Body Mass Index between 18 and 35 kg/m2
- Willingness and ability to follow clinical investigation protocol
- Grossly abnormal hip anatomy (hip dysplasia, Crowe Grade 2 or above, Perthes or other causes)
- Osteoporosis
- Paget's disease
- Inflammatory arthritis
- Secondary osteoarthritis
- Presence of malignancy in the area of surgery
- Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months or less prior to surgery
- Previous surgery in the affected hip
- Inclusion of the contralateral hip in this clinical investigation
- Not suited for the clinical investigation for other reason (surgeon's judgment)
- Pregnant or breastfeeding women
- Prison inmate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Early migration of the cup 2 years after operation Migration of the cup between 3 month and 2 years after implantation of the cup measured with Computed Tomography scan based Micromotion Analysis (CTMA) in mm.
- Secondary Outcome Measures
Name Time Method Long term wear 15 years after operation Liner wear measured in mm with CTMA
Patient reported outcome with Forgotten Joint Score 15 years after operation Patient-reported outcome measured by Forgotten Joint Score (FSJ). The scores will be summarized and transformed to a scale ranging from 0 to 100, where a high value indicate that the patient tends to be less aware of the affected joint when performing daily activities.
Reoperations 15 years after operation Incidence and rate of revisions, re-operations and operation-related complications
Osteolysis 15 years after operation Incidence and rate of patients showing osteolysis around the cup on CT scans and/or on x-rays
Proximal wear 5 years after operation Liner wear measured as proximal penetration of the femoral head prosthesis into the liner between 1 year and 5 years after operation in mm
3D wear 5 years after operation Liner wear measured as 3D penetration of the femoral head prosthesis into the liner between 1 year and 5 years after operation in mm
Stem migration 15 years Distal and 3D migration in mm of the stem between post- operative examination and 3 month, 3 month and 2 years, 3 month and 5 years and 3 month and 15 years.
Precision of migration measurements with CTMA 1 year after operation Precision of migration measurement in mm with CTMA, by comparing double CT scans obtained on the same day at the 1 year follow-up.
Long term migratio 15 years after operation Migration of the cup measured in mm with CTMA
Patient reported outcome with Hip dysfunction and Osteoarthritis Outcome Score 15 years after operation Patient-reported outcome measured by Hip dysfunction and Osteoarthritis Outcome Score (HOOS). Each of the 5 subscales will get a score of 0 to 100, with 0 indicating extreme symptoms and 100 indicating no symptoms. The subscales will be plotted as a HOOS profile, by connecting the mean scores for all 5 dimensions with a line.
Patient reported outcome with University of California, Los Angeles Activity Score 15 years after operation Patient-reported outcome measured by University of California, Los Angeles Activity Score (UCLA). The patients physical activity level rank from 1 (low) to 10 (high).
Patient reported outcome with EuroQuol 5. 15 years after operation Patient reported health related quality of life, measured by EuroQuol 5 dimensions (EQ-5D). For the calculation of the EQ-5D index the standard value set version 2.1 for Sweden is used. Index scores range from 0 ( 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Precision of wear mearurements with CTMA 1 year after operation Precision of wear measurement in mm with CTMA, by comparing double CT scans obtained on the same day at the 1 year follow-up.
Trial Locations
- Locations (1)
Volker Otten
🇸🇪Umeå, Västerbotten, Sweden
Volker Otten🇸🇪Umeå, Västerbotten, Sweden