Elbow FractureNCT03302533
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 of Elbow Fracture and Elbow Arthropathy, run by Diakoniekrankenhaus Friederikenstift.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elbow Fracture, Elbow Arthropathy
- What is being tested?
- Total elbow arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 21 Jan 2013to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Elbow Fracture, Elbow Arthropathy
- Being tested
- Total elbow arthroplasty
- Keywords
- distal humerus fracture, total elbow arthroplasty, elbow prosthesis, delayed arthroplasty, revision surgery
- Medical subject headings
- Elbow Fractures, Humeral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total elbow arthroplastyProcedure or surgery
Implantation of a total elbow arthroplasty after distal humerus fracture
| Study group | Role | What they receive |
|---|---|---|
| Primary arthroplasty | All patients who received TEA for an acute trauma with fracture of the distal humerus. Receives: 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. Receives: Procedure: Total elbow arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Measurement of the range of motion for extension/flexion
Measured: minimum follow-up: 6 months
Mayo Elbow Performance Score
Objective score evaluation the function of the elbow
Measured: minimum follow-up: 6 months
Secondary outcomes (1)
Complication
appearance of a complication
Measured: minimum follow-up: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start21 Jan 2013
- Primary completion31 Mar 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakoniekrankenhaus Friederikenstift
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexander Ellwein, Diakoniekrankenhaus Friederikenstift
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302533
- Sponsor's protocol ID
- 001-2017
- Status last verified
- Oct 2017
- First submitted
- 30 Sep 2017
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Secondary Total Elbow Arthroplasty After Failed Internal Fixation or Non-operative Treatment of Distal Humeral Fractures Achieve Equal Results as Primary Arthroplasty?
- ClinicalTrials.gov ID
- NCT03302533
- Acronym / sponsor ID
- 001-2017
- Conditions
- Elbow Fracture, Elbow Arthropathy
- Keywords
- distal humerus fracture, total elbow arthroplasty, elbow prosthesis, delayed arthroplasty, revision surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Diakoniekrankenhaus FriederikenstiftUniversity, hospital or other
- Study start
- 21 Jan 2013 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary arthroplasty | – | Procedure: Total elbow arthroplastyAll patients who received TEA for an acute trauma with fracture of the distal humerus. |
| Secondary arthroplasty | – | Procedure: Total elbow arthroplastyAll patients who received TEA due to a failed reconstruction or non-operative treatment after a distal humerus fracture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total elbow arthroplastyImplantation of a total elbow arthroplasty after distal humerus fracture | Procedure or surgery | Primary arthroplasty, Secondary arthroplasty |
Primary outcome
Range of motion
Time frame: minimum follow-up: 6 months
Measurement of the range of motion for extension/flexion
Mayo Elbow Performance Score
Time frame: minimum follow-up: 6 months
Objective score evaluation the function of the elbow
1 secondary outcome
Complication
Time frame: minimum follow-up: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Fracture and Elbow Arthropathy, run by Diakoniekrankenhaus Friederikenstift.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: minimum follow-up: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.