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Can Secondary Total Elbow Arthroplasty After Failed Internal Fixation or Non-operative Treatment of Distal Humeral Fractures Achieve Equal Results as Primary Arthroplasty?

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ClinicalTrials.gov Identifier: NCT03302533
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Alexander Ellwein, Diakoniekrankenhaus Friederikenstift

Brief Summary:
Total elbow arthroplasty (TEA) results in immediate pain release with good functional results after distal humerus fractures. But still open reduction and internal fixation is recommended as treatment of choise due to a lifelong loading limitiation, unknown implant survival and problematic revision surgery after TEA. The purpose of this study was to compare functional results and complication rates after primary total elbow arthroplasty (TEA) and TEA after failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal humerus fractures. We hypothesised that clinical and functional results are better for primary TEA with less complications.

Condition or disease Intervention/treatment
Elbow Fracture Elbow Arthropathy Procedure: Total elbow arthroplasty

Detailed Description:

Total elbow arthroplasty (TEA) results in immediate pain release with good functional results after distal humerus fractures. But still open reduction and internal fixation is recommended as treatment of choise due to a lifelong loading limitiation, unknown implant survival and problematic revision surgery after TEA. The purpose of this study was to compare functional results and complication rates after primary total elbow arthroplasty (TEA) and TEA after failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal humerus fractures.

This retrospective study was performed at a level I trauma centre. All patients were informed about the study and provided written informed consent.

All patients undergoing total elbow arthroplasty (TEA) were identified by electronically screening our database by the OPS codes 5-824.4 (implantation of a linked TEA) and 5-824.5 (implantation of an unlinked TEA) between August 2008 and May 2014. Based on patient records and x-rays the indication for implantation of the TEA was retrospectively reviewed. All patients, who received a TEA for an acute trauma with fracture of the distal humerus (primary TEA) or due to a failed reconstruction or non-operative treatment after a distal humerus fracture (secondary TEA), were included in this study. A minimum follow-up of 6 months was set as inclusion criterion. Exclusion criteria were previous injury at the fractured elbow, neuro-muscular disease, cortisone or other immune suppressive therapy and open fracture grade II or higher according to Tscherne and Ostern.The patient records were reviewed for demographic and perioperative data. If the initial treatment was not conducted in our department, radiographs and patient records were requested. The follow-up examination included the evaluation of the range of motion and stability of the elbow, actual pain and satisfaction of the patient. To objectify the functional result the Mayo Elbow Performance Score (MEPS) and Disabilities of the Arm, Shoulder and Hand Score (DASH) were determined. Additionally, complications and revision surgeries were recorded. Complications were split up into minor (nerve irritation or postoperative haematoma) and major complications, which required a revision of the prosthesis. Periprosthetic fractures due to renewed fall with an adequate trauma were not counted as complication.

Perioperative data, the functional result (range of motion, MEPS, DASH) and postoperative complications were described for each group. Subsequently, these results were statistically compared using the Mann-Whitney U test as a two-way analysis of variance for independent factors. A p-value ≤ 0.05 was considered statistically significant. The statistical analysis was performed using SPSS for MAC (IBM SPSS Statistics 22, Chicago, Illinois).

We hypothesised that clinical and functional results are better for primary TEA with less complications.

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Actual Study Start Date : January 21, 2013
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Primary arthroplasty
All patients who received TEA for an acute trauma with fracture of the distal humerus.
Procedure: Total elbow arthroplasty
Implantation of a total elbow arthroplasty after distal humerus fracture

Secondary arthroplasty
All patients who received TEA due to a failed reconstruction or non-operative treatment after a distal humerus fracture.
Procedure: Total elbow arthroplasty
Implantation of a total elbow arthroplasty after distal humerus fracture




Primary Outcome Measures :
  1. Range of motion [ Time Frame: minimum follow-up: 6 months ]
    Measurement of the range of motion for extension/flexion

  2. Mayo Elbow Performance Score [ Time Frame: minimum follow-up: 6 months ]
    Objective score evaluation the function of the elbow


Secondary Outcome Measures :
  1. Complication [ Time Frame: minimum follow-up: 6 months ]
    appearance of a complication


Other Outcome Measures:
  1. DASH score [ Time Frame: minimum follow-up: 6 months ]
    Disabilities of the Arm, Shoulder and Hand: subjective score evaluation the function



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Out of 35 patients, who fit the inclusion criteria, six had died from unrelated causes. 23 patients participated in the study, since six patients were lost to follow-up. Nine of the 23 patients (mean age: 70 years; 8 women) had implantation of a primary TEA. The remaining 14 patients (mean age: 63 years; 11 women) received secondary implantation of a TEA. The secondary TEA was implanted after an implant failure in four patients, twice because of a non-union (one after reconstruction and one after non-operative therapy), and in three patients because of a non-union with an additional partial necrosis of the distal humerus. Two patients received secondary TEA because of a posttraumatic arthritis after internal fixation and three times because of a posttraumatic arthritis after non-operative treatment. The mean follow-up was 28 months (range: 6 - 73) with a mean age of 66 years (range: 41 - 85).
Criteria

Minimum age: 18 years Sex: All

Inclusion Criteria:

  • Total elbow arthroplasty for an acute trauma with fracture due to an acute trauma
  • Total elbow arthroplasty due to failed reconstruction after distal humerus fracture
  • Total elbow arthroplasty after non-operatic treatment after distal humerus fracture

Exclusion Criteria:

  • previous injury at the fractured elbow
  • neuro-muscular disease
  • cortisone or other immune suppressive therapy
  • open fracture grade II or higher according to Tscherne and Ostern
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Responsible Party: Dr. Alexander Ellwein, Assistant Physician, Diakoniekrankenhaus Friederikenstift
ClinicalTrials.gov Identifier: NCT03302533    
Other Study ID Numbers: 001-2017
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Alexander Ellwein, Diakoniekrankenhaus Friederikenstift:
distal humerus fracture
total elbow arthroplasty
elbow prosthesis
delayed arthroplasty
revision surgery
Additional relevant MeSH terms:
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Joint Diseases
Fractures, Bone
Wounds and Injuries
Musculoskeletal Diseases