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CompletedNCT03302533Updated Oct 5, 2017

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

An observational study in Elbow Fracture and Elbow Arthropathy, sponsored by Diakoniekrankenhaus Friederikenstift. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-05.

Sponsored by Diakoniekrankenhaus Friederikenstift · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
23
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Elbow Fracture
  • Elbow Arthropathy

Keywords

  • distal humerus fracture
  • total elbow arthroplasty
  • elbow prosthesis
  • delayed arthroplasty
  • revision surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).

Minimum age: 18 years Sex: All

Inclusion criteria

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

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
04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
23 participants (actual)
Patient registry
No

Groups and cohorts

  • Primary arthroplasty

    All patients who received TEA for an acute trauma with fracture of the distal humerus.

    Procedure: Total elbow arthroplasty

  • 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

Interventions

  • ProcedureTotal elbow arthroplasty

    Implantation of a total elbow arthroplasty after distal humerus fracture

05

What researchers measure

Primary outcomes

  1. Range of motion

    Measurement of the range of motion for extension/flexion

    Time frame: minimum follow-up: 6 months

  2. Mayo Elbow Performance Score

    Objective score evaluation the function of the elbow

    Time frame: minimum follow-up: 6 months

Secondary outcomes

  1. Complication

    appearance of a complication

    Time frame: minimum follow-up: 6 months

Other outcomes

  1. DASH score

    Disabilities of the Arm, Shoulder and Hand: subjective score evaluation the function

    Time frame: minimum follow-up: 6 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03302533
Lead sponsor
Diakoniekrankenhaus Friederikenstift
Responsible party
Dr. Alexander Ellwein (Assistant Physician, Diakoniekrankenhaus Friederikenstift) — Principal investigator
First posted
Oct 5, 2017
Start date
Jan 21, 2013
Primary completion
Mar 31, 2016
Completion
Mar 31, 2017
Last update
Oct 5, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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