Loading...
Visit our Evidence-Based Covid-19 Website and Stay Up to Date with the latest Research.
Author Verified
RCT
ACE Report #3383

Tibial fractures: Alpha-BSM comparable to autogenous bone graft in preventing subsidence


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Comparison of autogenous bone graft and endothermic calcium phosphate cement for defect augmentation in tibial plateau fractures. A multicenter, prospective, randomized study

J Bone Joint Surg Am. 2008 Oct;90(10):2057-61

Contributing Authors: TA Russell RK Leighton

Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here

Synopsis

119 patients presenting with acute, closed, unstable tibial plateau fractures (120 fractures) were randomized to undergo standard open reduction and internal fixation with either a bioresorbable calcium phosphate cement (alpha-BSM) or an autogenous iliac bone graft. The results after a 12 month follow-up indicated that the use of alpha-BSM was superior in reducing articular subsidence compared to autogenous iliac bone graft.

Publication Funding Details +
Funding:
Industry funded
Sponsor:
DePuy and ETEX Corp.
Conflicts:
Other

Risk of Bias

8/10

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.

3/4

Randomization

4/4

Outcome Measurements

2/4

Inclusion / Exclusion

3/4

Therapy Description

2/4

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?

For patients with defects resulting from unstable tibial plateau fractures, use of the autogenous iliac bone graft is considered the standard choice of treatment. However, there are reported disadvantages and complications associated with this procedure. Prevention of articular surface collapse is the primary goal of autogenous grafting to treat subarticular defects; however, the use of artificial material with internal fixation may provide the necessary benefits and support for the articular surface. Few in vivo studies have demonstrated the benefits of a calcium phosphate cement (alpha-BSM) over bone grafts indicating the need for more trials evaluating the effectiveness of the alpha-BSM.

What was the principal research question?

Is the use of a calcium phosphate cement (alpha-BSM) as effective as autogenous iliac bone graft in the treatment of subarticular bone defects resulting from tibial plateau fractures, measured over a 12 month time period?

Study Characteristics -
Population:
120 acute, closed, unstable tibial plateau fractures (n=119 patients; 73 male, 46 female; average age=43 years).
Intervention:
Bioresorbable group: Patients received open reduction and internal fixation using bioresorbable calcium phosphate cement (alpha-BSM) (n=82 fractures).
Comparison:
Control group: Patients received open reduction and internal fixation using a standard autogenous iliac bone graft (n=38 fractures).
Outcomes:
Fracture union, articular subsidence, loss or premature resorption of graft, infection, effect of tobaco use, and knee range of motion were measured.
Methods:
RCT; Multiple Centres
Time:
Follow up at 6 weeks, 3, 6 and 12 months post-operatively.

What were the important findings?

  • There was no significant difference regarding the age, height, weight, sex and fracture patterns of the patients between the two groups.
  • There was no difference between the two treatment groups with respect to union or the frequency of union, and infections.
  • There was no dissolution in either the bone graft of the alpha-BSM prior to fracture union, evidenced by the absence of radiolucent zones on radiographs. No patients in either of the treatment groups had loss of internal fixation.
  • During the 3-12 month follow up period, the autogenous bone graft group had a significantly higher rate of articular subsidence compared to the alpha-BSM group (subsidence of 2mm or greater in 30% of autogenous graft patients vs. 9% of alpha-BSM patients) (p=0.009).
  • The alpha-BSM group demonstrated a greater improvement in range of motion compared to the autogenous graft group (not significant difference).

What should I remember most?

This study demonstrated that alpha-BSM, for the intervention of tibial plateau fractures, resulted in similar and possibly better mechanical support when compared to autogenous bone grafts, as less subsidence was observed in patients treated with alpha-BSM.

How will this affect the care of my patients?

Patients with unstable tibial plateau fractures may receive comparable outcomes when treated with alpha-BSM compared to autogenous iliac bone graft. As this is one of the first studies investigating alpha-BSM in comparison to autogenous iliac bone graft, further trials are need to establish alpha-BSM as an adequate augmentation to open reduction and internal fixation of unstable tibial plateau fractures.

CME Image

Continuing Medical Education Credits

You could be earning 0.5 CME credits for each report you read.

LEARN MORE

Please Login or Join to leave comments.