A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement

NCT01289834 | Completed DMC

• 1 other identifier: VEK20100112
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this scientific study is to compare early migration of hip prostheses in respect to the bone in order to determine whether there is a clinical difference between the two investigated bone cements (which one is best suited for cementation of hip prostheses).

Conditions

Hip Arthritis

Keywords

RSA; Bone Cement

Outcome Measures

Primary Outcomes (1)

• Femoral component migration (roentgen stereo photogrammetric analysis - RSA)

  Migration of the femoral component is measured over time and in respect to the femur bone.

  2 years

Study Arms (2)

Hi-Fatigue Bone Cement

ACTIVE COMPARATOR

CPT femoral stems fixed with Hi-Fatigue Bone Cement

Device: Hi-Fatigue Bone Cement

Palacos Bone Cement

ACTIVE COMPARATOR

CPT femoral stems fixed with Palacos Bone Cement

Device: Palacos Bone Cement

Interventions

Hi-Fatigue Bone Cement DEVICE

Hi-Fatigue bone cement is a new development of Aap Biomaterials, GmbH \& Co that has not yet been tested in the clinical setting. Hi-Fatigue has a medium to low viscosity. Laboratory tests confirm Hi-Fatigue bone cement to have properties equivalent to or better than the golden standard bone cement" Palacos. Hi-Fatigue is to be used without pre-chilling. When mixed at a room temperature of 21°C Hi-Fatigue has a low initial viscosity improving mixing and theoretically reducing the porosity of the cured cement.

Hi-Fatigue Bone Cement

Palacos Bone Cement DEVICE

Palacos Bone Cement has been used for 48 years and has a good reputation as the "gold standard" among bone cements (3). It is a high-viscosity cement with rapid application that makes it advantageous for use in orthopedic joint surgery. Palacos cement was developed in order to allow hand mixing of monomers and polymers in a dish in the operating room. Air pollution with toxic monomers in the operating room was a problem that was primarily solved by exhaust ventilation, later supplemented with vacuum mixing

Palacos Bone Cement

Eligibility Criteria

• Age: 71 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• primary hip osteoarthritis
• sufficient bone quality for total hip arthroplasty
• age 71 years and above
• no upper age limit if the patient is capable
• informed and written consent
• patient can only enter the project with one hip

You may not qualify if:

• planned bilateral hip surgery
• neuromuscular or vascular disease in the affected leg
• preoperatively not found suitable for a hip arthroplasty
• patients with osteoporosis based on former diagnosis or preoperative DEXA-scan
• fracture sequelae, osteonecrosis or previous extensive hip surgery
• patients who cannot refrain from taking NSAID post-operatively
• continuous medical treatment with vitamin K antagonists (Warfarin) which is known to reduce the bone mass by a factor of 5
• patients with metabolic bone disease
• patients with rheumatoid arthritis
• postmenopausal women in systemic estrogenic hormone substitution
• patients with a continuous need of systemic cortisone treatment
• non-Danish citizenship
• patients who do not comprehend the Danish language (read and speak)
• senile dementia
• alcoholism - defined as men drinking more than 21 units a week and women drinking more than 14 units a week

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Zimmer Biomet: collaborator

Study Sites (1)

Kjeld Soballe, Orthopaedic center, University of Aarhus

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.

  PMID: 36422666 DERIVED

Study Officials

• Kjeld Soballe, Professor MD

  Orthopaedic Center, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: February 4, 2011
• Study Start: August 1, 2010
• Primary Completion: April 1, 2016
• Study Completion: January 1, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

DK (1)