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Active, Not Recruiting

NCT Number: NCT05773261

Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Volker Otten

Umeå, Västerbotten County, 907 37, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MobilLINK TrabecuLINK cup

Device

THA with MobilLINK TrabecuLINK cup and LCU stem

Pinnacle Gription cup

Device

THA with Pinnacle Gription cup and Coral stem

Primary outcomes

  1. Early migration of the cup

    Time frame: 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 outcomes

  1. Proximal wear

    Time frame: 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

  2. 3D wear

    Time frame: 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

  3. Long term migratio

    Time frame: 15 years after operation

    Migration of the cup measured in mm with CTMA

  4. Long term wear

    Time frame: 15 years after operation

    Liner wear measured in mm with CTMA

  5. Stem migration

    Time frame: 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.

  6. Patient reported outcome with Forgotten Joint Score

    Time frame: 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.

  7. Patient reported outcome with Hip dysfunction and Osteoarthritis Outcome Score

    Time frame: 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.

  8. Patient reported outcome with University of California, Los Angeles Activity Score

    Time frame: 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).

  9. Patient reported outcome with EuroQuol 5.

    Time frame: 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.

  10. Reoperations

    Time frame: 15 years after operation

    Incidence and rate of revisions, re-operations and operation-related complications

  11. Osteolysis

    Time frame: 15 years after operation

    Incidence and rate of patients showing osteolysis around the cup on CT scans and/or on x-rays

  12. Precision of migration measurements with CTMA

    Time frame: 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.

  13. Precision of wear mearurements with CTMA

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Västerbotten
  • University Hospital, Umeå

Registry information

Official study title

Modern Surfaces of the Uncemented Cup in Total Hip Arthroplasty: A Randomized, Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups Using CT-based Micromotion Analysis and Clinical Evaluation

Important dates

Study start
2022
Primary completion
2026
Study completion
2039
First posted
Mar 17, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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