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No significant difference in 10-yr migration between high & low viscosity cement in THA

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No significant difference in 10-yr migration between high & low viscosity cement in THA

Vol: 6| Issue: 2| Number:1| ISSN#: 2564-2537
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Palacos compared to Palamed bone cement in total hip replacement: a randomized controlled trial

Acta Orthop. 2016 Oct;87(5):473-8

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Synopsis

39 patients scheduled for cemented total hip arthroplasty were randomized to receive either low viscosity bone cement or high viscosity bone cement. The purpose of this study was to compare femoral component migration via radiostereometric analysis (RSA) over a 10-year follow-up. The results of this study demonstrated no significant differences between groups in femoral component translation or rotation over the follow-up.

Publication Funding Details +
Funding:
Industry funded
Sponsor:
Biomet
Conflicts:
None disclosed

Risk of Bias

5.5/10

Reporting Criteria

14/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

2/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

2/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Aseptic loosening of components in cemented total hip arthroplasty is the most common reason for revision and has been suggested to be predicted by early, short-term migration. High and medium viscosity bone cement have traditionally been used, with low viscosity bone cement more recently introduced. It is unknown if early migration, and ultimately revision rates, significantly differ between high and low viscosity bone cement.

What was the principal research question?

In cemented total hip arthroplasty, is there any significant difference in radiostereometric analysis of component migration between components fixed with low viscosity bone cement (Palamed) versus high viscosity bone cement (Palacos) over a 10-year follow-up?

Study Characteristics -
Population:
Forty hips in 39 patients, over the age of 65, scheduled for primary total hip arthroplasty due to osteoarthritis. All cases were performed through a direct lateral approach, used the same femoral stem (Stanmore; Biomet), 28-mm femoral head, and ultra-high-molecular-weight polyethylene acetabular cup.
Intervention:
Palamed group: Cement fixation was performed using a low viscosity bone cement (Palamed) prepared via vacuum-mixing.
Comparison:
Palacos group: Cement fixation was performed using a high viscosity bone cement (Palacos) prepared via vacuum-mixing
Outcomes:
Radiostereometric analysis (RSA) was used to assess 3-dimensional translation and rotation of the femoral component, as well as maximum total point motion (MTPM). Standard radiographs were used to assess component orientation and the incidence of radiolucency. The Harris Hip Score was used to assess clinical outcome.
Methods:
RCT
Time:
Follow-up scheduled for 6 weeks, 3, 6, 12 months, and yearly thereafter.

What were the important findings?

  • Only 12 patients were available for the 10-year follow-up.
  • No significant difference between groups in mediolateral, craniocaudal, or anteroposterior translation of the femoral component was observed over 10-year follow-up (p=0.5, 0.4, and 0.9, respectively).
  • Maximum total point motion also did not significantly differ between the Palamed group (1.3mm [95%CI 0.88-1.8]) and the Palacos group (1.3mm [95%CI 0.56-2.1]) after 10 years (p=0.7).
  • No significant difference between groups in mediolateral, craniocaudal, or anteroposterior rotation of the femoral component was observed over 10-year follow-up (p=0.6, 0.9, and 0.6, respectively).
  • There were no differences in the Harris Hip Score at any time point between the two groups.

What should I remember most?

In cemented total hip arthroplasty, there was no significant difference in femoral prosthesis migration after 10 years between components fixed with a low viscosity bone cement (Palamed) and components fixed with a high viscosity bone cement (Palacos).

How will this affect the care of my patients?

The results of this study suggest that low viscosity Palamed bone cement and high viscosity Palacos cement demonstrate similar long-term stability of the femoral component in cemented total hip arthroplasty. The similar results observed with these two types of cement suggest that decisions regarding the cement used should be left to the discretion of the surgeon. However, it should be noted that the limited number of patients still available at the 10-year follow-up limited the ability to detect significant differences.

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