The Ace Avanteon Study - A Randomized Controled Trial

NCT06499038 | Recruiting

• 1 other identifier: 536698
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controled trial is to compare if using of ancillary screws yields equal results as no use of ancillary screws in the ACE acetabulum cup of a total hip arthroplasty. Further, the migration of the Avanteon stem over time will be assessed. Patients included are patients with hip osteoarthritis from 65-80 years old. The purpose of this study is to compare implant migration and early fixation of a hybrid hip replacement combining the uncemented ACE acetabular component and the cemented Avanteon femoral stem, by using CT based Radiostereometric Analysis, a new innovative method for evaluating implant migration. Our study may predict the long term survival of the implants used. Participants will go through total hip arthroplasty, and be followed by CT-RSA, plain x-rays and patients reported outcome measures.

Conditions

Hip Osteoarthritis

Keywords

, Total Hip Arthroplasty,; Total Hip Replacement; CT-RSA; CTMA; Migration study

Outcome Measures

Primary Outcomes (1)

• Translation

  Proximal Y migration acetabular cup measured by CT-RSA

  2 years

Secondary Outcomes (6)

• Rotation

  2 years

• Migration

  2 years

• MTPM

  2 years

• Stem Tr

  2 years

• XZ translation of Avanteon stem

  2 years

Other Outcomes (2)

• Difference precision

  3 months

• PROMs

  2 years

Study Arms (2)

Ancillary screw group

EXPERIMENTAL

Patients with ancillary screw fixation acetabular component

Procedure: Total Hip Arthroplasty

Without ancillary screws group

ACTIVE COMPARATOR

No ancillary screws in acetabular component

Procedure: Total Hip Arthroplasty

Interventions

Total Hip Arthroplasty PROCEDURE

Surgery for total hip replacement

Also known as: ACE cup and Avanteon Stem

Ancillary screw group; Without ancillary screws group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with primary hip osteoarthritis between the age of 65 and 80 years at time of surgery
• Patients requiring primary total hip replacement
• Patients who understand the conditions of the study, are willing to, and able to comply with the postoperative scheduled clinical and radiographic evaluations

You may not qualify if:

• Patients who are unable to provide informed consent
• Patients who require revision hip arthroplasty
• Patients who have had a previous osteotomy or osteosynthesis of the femur or acetabulum
• Patients with metabolic bone disease, other than osteoporosis
• Patients with inflammatory arthritis
• Obese patients where obesity is severe enough to affect the patient's ability to perform activities of daily living (BMI \> 40)
• Patients with active or suspected infection
• Patients with malignancy
• Patients unable to cooperate caused by language or psychosocial conditions

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• St. Olavs Hospital: collaborator
• JRI Orthopaedics Ltd: collaborator

Study Sites (1)

Kristiansund Hospital, Møre and Romsdal Hospital Trust

Kristiansund, Møre and Romsdal, 6508, Norway

RECRUITING

Related Publications (33)

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• Otten VT, Crnalic S, Rohrl SM, Nivbrant B, Nilsson KG. Stability of Uncemented Cups - Long-Term Effect of Screws, Pegs and HA Coating: A 14-Year RSA Follow-Up of Total Hip Arthroplasty. J Arthroplasty. 2016 Jan;31(1):156-61. doi: 10.1016/j.arth.2015.07.012. Epub 2015 Jul 11.

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Related Links

• ICMJE recommendations

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Frank-David Øhrn, MD, PhD

  Møre og Romsdal Hospital Trust

  STUDY CHAIR

• Mathias Brevik, MD

  Møre og Romsdal Hospital Trust

  PRINCIPAL INVESTIGATOR

• Otto Schnell Husby, Professor

  Norwegian University of Science and Technology

  STUDY DIRECTOR

• Kirsti Sevaldsen, MD, PHD

  Møre og Romsdal Hospital Trust

  STUDY CHAIR

Central Study Contacts

Myrthle Hoel, Nurse

CONTACT

71120000; Myrthle.Slettvag.Hoel@helse-mr.no

Mathias Brevik, MD

CONTACT

71120000; mathias.fjellingsdal.brevik@helse-mr.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controled trial

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 12, 2024
• Study Start: August 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From 3 years from now and as long as the data is stored.
• Access Criteria: Proper request to the corresponding author.

Locations

NO (1)