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Intertrochanteric fractures: Similar rate of reoperation using fixed or sliding side plate
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TRAUMA

A multicentre, prospective, randomised comparison of the sliding hip screw with the Medoff sliding screw and side plate for unstable intertrochanteric hip fractures
Verified
This report has been verified by one or more authors of the original publication.

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2014;2(7):39 Injury. 2013 Dec;44(12):1904-9. doi: 10.1016/j.injury.2013.06.017. Epub 2013 Jul 20

163 patients with unstable intertrochanteric fractures were randomized to receive surgical treatment using either (1) a sliding hip screw and fixed side plate or (2) a sliding hip screw and a Medoff sliding side plate. The purpose of this study was to compare rates of re-operation and hip function scores following treatment with these two types of hardware. Results after 6 months indicated that the use of a sliding hip screw with a Medoff sliding side plate resulted in a similar re-operation rate, hip function recovery scores, length of hospital stay, haemoglobin drop, number of transfusions, transfusion units, leg-length discrepancy, loss in range of motion, and the incidence of complications. Surgical time was significantly greater in the Medoff sliding side plate group.


出版資金提供の詳細 +
資金提供:
Not Reported
コンフリクト:
None disclosed

バイアスのリスク

6/10

報告基準

16/20

脆弱性指数

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)?

はい = 1

不確実=0.5

無関係 = 0

いいえ = 0

報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。

2/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

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

Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。

なぜ今この研究が必要なのですか?

Hip screws are used in the treatment of unstable intertrochanteric hip fractures, however the average failure rate for this treatment remains quite high (15%). As to be expected, this high failure rate may lead to a significantly higher number of re-operations, resulting in increased patient morbidity and health care costs. Previously, when sliding hip screws were introduced into practice, failure rates significantly dropped. Based on this reasoning, it has been suggested that the implementation of both sliding hip screws and sliding plates in the treatment of unstable intertrochanteric hip fractures may result in improved re-operation rates and patient function.

主な研究課題は何ですか?

How does the use of a sliding hip screw and a sliding side plate compare to the use of a sliding hip screw and fixed side plate in the treatment of unstable intertrochanteric fractures, with respect to re-operation rate and patient function assessed at 6 months postoperatively?

研究の特徴 +
人口:
163 patients (median 83 years old) with unstable intertrochanteric hip fractures (Jensen and Michaelsen Type IV and V fractures; OTA 31-A2 fractures) (124 females; 39 males).
介入:
MSP group: Patients in this group (n=77) underwent surgical treatment of their intertrochanteric hip fracture using a sliding hip screw with a Medoff sliding side plate (MSP; Wright Medical Group, Arlington, TN, USA). The sliding Medoff 135-degree side plate (MSP) was placed over the hip screw and fixed with cortical screws. (Mean age: 83.6 years; 18 males, 59 females).
比較:
DHS group: Patients in this group (n=86) underwent surgical treatment of their intertrochanteric hip fracture using a sliding hip screw with a fixed side plate (dynamic hip screw, DHS; Synthes (Canada) Ltd., Mississauga, ON, USA). The fixed Synthes 135-degree plate (four holes) was placed over the hip screw and fixed with cortical screws. (Mean age: 83 years; 21 males, 65 females).
アウトカム:
The primary outcome was re-operation rate. Secondary outcomes included patient function (assessed using the Geriatric Hip Fracture Recovery Score (GHFRS)), morbidity, mortality, hospital stay, quality of reduction, and the incidence of non-union/malunion (assessed using radiographic imaging).
方法:
RCT; Multi-Centre
時間:
Follow-up assessments took place 4-6 weeks, 3-4 months and 6 months postoperatively.

重要な知見は?

  • Re-operation rates due to hardware failure were statistically similar between groups (3 in the DHS group [3.7%] and 2 in the MSP group [2.5%]; p>0.05). Two other re-operations were perfomed (both in the DHS group); 1 for wound debridement and 1 for hardware removal.
  • 6 patients in the MSP group and 1 patient in the DHS group experienced non-unions within the first 6 postoperative months. .
  • Hip recovery scores significantly improved from baseline to the 6-month follow-up in both groups (MSP: p<0.001; DHS: p=0.03). There were no significant between-group differences in hip recovery (MSP: 49.7%; DHS: 51.0%; p>0.05).
  • Median surgical time was significantly lower in the DHS group (50 minutes) compared to the MSP group (56 minutes) (p=0.01).
  • Tip-apex distance, as measured with radiographic images, was significantly greater in the MSP group at 6 months (p=0.02). There was no significant difference in neck-shaft angle between groups (p>0.05).
  • There was no significant difference between groups in length of hospital stay, haemoglobin drop, number of transfusions, transfusion units, leg-length discrepancy, loss in range of motion, and the incidence of complications (p>0.05).
  • At 6 months, 18 patients in the DHS group and 11 patients in the MSP group had died, a non-significant difference (p>0.05).
最も覚えておくべきことは?

At 6 months, in patients with unstable intertrochanteric fractures, the use of a sliding hip screw with a Medoff sliding side plate resulted in a similar re-operation rate, hip function recovery scores, length of hospital stay, haemoglobin drop, number of transfusions, transfusion units, leg-length discrepancy, loss in range of motion, and the incidence of complications. Surgical time was significantly greater with the Medoff sliding side.

それが私の患者ケアにどのように影響するか?

Results from this study suggest that, in patients with unstable intertrochanteric fractures, the use of a sliding hip screw with a Medoff sliding side plate provides similar short-term outcome to that of a sliding hip screw with a fixed side plate. Additional higher-powered studies, using surgeons of known similar experience, are required to verify these findings.

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引用方法 ACE Report

OrthoEvidence. Intertrochanteric fractures: Similar rate of reoperation using fixed or sliding side plate. OE Journal. 2014;2(7):39. Available from: https://myorthoevidence.com/AceReport/Show/intertrochanteric-fractures-similar-rate-of-reoperation-using-fixed-or-sliding-side-plate

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