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A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT00940446
Recruitment Status : Completed
First Posted : July 16, 2009
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
OrthoIndy
Information provided by (Responsible Party):
Orthopaedic Research Foundation

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions: Erythema
Drainage
Bruising
Pain
Interventions: Device: Insorb staples
Device: metal staples (Ethicon metal stapler)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Insorb Staples

Subcuticular Absorbable staples

Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples.

Control

Metal staple wound closure

Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure.


Participant Flow:   Overall Study
    Insorb Staples   Control
STARTED   30   30 
COMPLETED   30   30 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Insorb Staples Subcuticular Absorbable staples
Control Metal staple wound closure
Total Total of all reporting groups

Baseline Measures
   Insorb Staples   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Years]
Median (Full Range)
 62.3 
 (45 to 82) 
 61.9 
 (41 to 82) 
 61.9 
 (41 to 82) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female      15  50.0%      20  66.7%      35  58.3% 
Male      15  50.0%      10  33.3%      25  41.7% 
[1] number and sex of study participants
Number of staples placed [1] 
[Units: Staples]
 465   597   1062 
[1] we counted the number of staples used, collectively for all participants. This is a baseline number used for outcomes comparisons.


  Outcome Measures

1.  Primary:   Participants With Incisional Drainage, Swelling or Gaps of Incision   [ Time Frame: Discharge from initial hospital stay (2-5 days post-op) ]

2.  Secondary:   Participants With Wound Complications - Hematoma   [ Time Frame: up to 6 weeks post-op ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr David A Fisher
Organization: OrthoIndy
phone: (317) 802-2000
e-mail: dafisher@orthoindy.com



Responsible Party: Orthopaedic Research Foundation
ClinicalTrials.gov Identifier: NCT00940446     History of Changes
Other Study ID Numbers: DAF_PC000001
First Submitted: July 14, 2009
First Posted: July 16, 2009
Results First Submitted: April 3, 2017
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018