Olecranon FractureWOW-OKNCT05657899
The With Or Without Olecranon K-wires Trial
A study testing Cerclage fixation and Tension band wiring in people with Olecranon Fracture, run by Region Skane at 2 sites in Sweden.
Trial summary
Fractures of the elbow tip (olecranon) that leave the elbow joint stable but where the fracture ends are separated (Mayo type 2a and 2b) can be treated with pins and a metal wire (tension band wiring, TBW) or metal wiring alone (cerclage fixation, CF ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olecranon Fracture
- What is being tested?
- Cerclage fixation and Tension band wiring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jan 2023to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sustained Olecranon type fracture of Mayo 2a or 2b
- Seeking healthcare in at the Skåne University Hospital in Lund and Malmö, Sweden.
Who cannot join
- Subjects unable to participate in follow up (for example subjects with active substance abuse, dementia, inability to communicate or understand the questionnaires or subjects living in other administrative healthcare regions).
- Subjects unable to give informed written consent.
- Subject where non operative treatment is indicated due to frailty or severe ongoing disease.
- Fracture not operated within 14 days from the date the fracture was sustained.
- Subjects with severe open fractures of Gustilo-Anderson class III
- Subject with pathological fractures from metastatic disease.
Show all 9Show fewer
- Subject with simultaneous or previous severe injury to the same arm are excluded for patient reported outcome measures but included for all other outcomes.
- Subjects with previously severe injuries to the same arm will be excludes for PROM analyses but included for reoperation and complication analyses.
- Subjects operated by an orthopedic trauma surgeons that did not attended our education on the study and the interventions, unless surgery is supervised by an orthopedic surgeon that has attended the education the subject will not be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Dept. of Orthopaedics
Lund, Skåne County, 22242
Gustav Cornefjord, MD, gustav.cornefjord@med.lu.se
Daniel Wenger, MD, PhD, daniel.wenger@med.lu.se
- Recruiting
Dept. of Orthopaedics
Malmö, Skåne County, 20502
Daniel Wenger, MD, PhD, daniel.wenger@med.lu.se
Gustav Cornefjord, MD, gustav.cornefjord@med.lu.se
About this study
Official title: The With Or Without Olecranon K-wire (WOW OK) Trial of Tension Band Wire Fixation Versus Cerclage Fixation Without K-wires in Displaced Stable Olecranon Fractures
Fractures of the elbow tip (olecranon) that leave the elbow joint stable but where the fracture ends are separated (Mayo type 2a and 2b) can be treated with pins and a metal wire (tension band wiring, TBW) or metal wiring alone (cerclage fixation, CF ). Previous studies have reported high re-operation and complication rates following TBW. The current study's hypothesis, based on two retrospective studies, is that CF of these fractures yield lower re-operation rates compared with TBW. The investigators also hypothesize that the overall complication rate will be lower following CF. The aim is to investigate this hypothesis in a randomized controlled trial. Patients that are 18 years or older with Mayo type 2a and 2b olecranon fractures at Skåne University hospital will be invited to the study. Participation is voluntary. Patients who accept participation will be randomly assigned to surgery by either TBW or cerclage fixation. Two hundred participants will be followed by physiotherapists for 36 months post-surgery assessing re-operations, complications, patient reported outcome, and elbow function.
Read the detailed description
The complete study protocol including a detailed description of the trial will be published in a journal before the start of the trial.
Olecranon fractures account for approximately 20% of all proximal fractures of the forearm. Stable, undisplaced fractures (Mayo type 1a and 1b) are routinely treated non-operatively, while displaced and unstable fractures (Mayo type 3a and 3b) are typically operated with plate fixation. Stable, displaced fractures (Mayo type 2a and 2b) are often treated with tension band wiring (TBW) or plate fixation. TBW is associated with soft tissue irritation and high re-operation rates with hardware removal, ranging from 25% to 84% in the literature. Plate fixation was associated with fewer re-operations compared with TBW in a randomized controlled trial, but complications following plate fixation were more severe. A Cochrane review from 2014 did not find any significant support favouring either of the two methods. Non-operative treatment of Mayo type 2a and 2b fractures can yield acceptable results in elderly patients, but is not routinely used in younger individuals with higher functional demands. Two previous retrospective studies from 2002 and 2021 reported that Mayo 2a and 2b fractures can be operated with cerclage fixation alone yielding half the re-operation rates when compared to TBW. As of April 2022 there are two studies (one active (NCT03280602) and one completed (NCT01391936)) comparing TBW vs plate fixation, three studies (two active (NCT04670900 and NCT04401462) and one terminated (NCT01397643)) comparing non-operative vs operative treatment in elderly and one active study (NCT04189185) comparing TBW vs suture fixation registered on this site. The hypothesis of the current study is that the re-operation rate and the complication rate will be lower following CF compared with TBW while yielding equal results in other outcome measures. The aim is to to investigate this in a prospective randomized clinical trial.
Methodology:
All patients presenting at Skåne University Hospital in Malmö and Lund, Sweden, with olecranon fractures of Mayo type 2a and 2b will be invited to participate in the study if they do not meet any exclusion criteria. Potential subjects will be asked to sign a consent form after receiving written and oral information about the trial. Subjects will be randomized 1:1 to surgery with TBW or cerclage. 200 subjects will be recruited based on sample size calculations derived from the re-operation frequency in a previous study (PMID: 34236459)
Baseline descriptive data will be collected at inclusion or in the peri-operative period. Operation time, intra-operative effective radiation dose and radiation time will be recorded. Subjects will be invited to follow-up to a physiotherapist at 2 weeks, 6 weeks, 3 months, 12 months and 36 months after the operation assessing re-operations, complications, post-operative antibiotics, range of elbow motion, grip strength, the Quick Disabilities of the Arm, Shoulder and Hand score (Quick-DASH, references PMID: 8773720 and 6709254), overall patient satisfaction, pain, return to work and secondary dislocation. The Short Musculoskeletal Function Assessment (SMFA, references PMID: 27994082 and 14763711) score will be assessed 12 months post-operatively. The physiotherapist will be masked to the treatment method. At 6 months one radiograph will be collected for assessment of non-union.
The primary outcome measure will be re-operations. Secondary outcome measures will be patient reported outcome measures and complications. Tertiary outcome measures are post-operative range of motion and grip strength, secondary dislocation rate, time to return to work after surgery, operation time, effective intra-operative radiation dose and radiation time. The hypothesis of the current study is that cerclage fixation will yield less re-operations, less overall complications and less severe complications while other outcome measures will be equal.
- Conditions
- Olecranon Fracture
- Being tested
- Cerclage fixation, Tension band wiring
- Keywords
- Tension Band Wiring, Cerclage, Surgery, Elbow injuries, Forearm injuries, Ulna fractures, Patient reported outcome measures
- Medical subject headings
- Olecranon Fracture, Elbow Injuries, Forearm Injuries, Ulna Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerclage fixationProcedure or surgery
The intervention is by surgical open reduction and internal fixation of the fracture using two 1.0mm cerclage.
Tension band wiringProcedure or surgery
The intervention is by surgical open reduction and internal fixation of the fracture using a 1.0mm cerclage and two 1.6 mm k-wires as described in AO-guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Cerclage | Active comparator | Intervention by cerclage fixation. Receives: Procedure: Cerclage fixation |
| Tension Band Wiring | Active comparator | Intervention by tension band wiring Receives: Procedure: Tension band wiring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operation rate 1.5 months.
Total re-operation rate of the operated elbow regardless of cause.
Measured: Recorded at 1.5 months after intervention.
Re-operation rate 3 months.
Total re-operation rate of the operated elbow regardless of cause.
Measured: Recorded at 3 months after intervention.
Re-operation rate 12 months.
Total re-operation rate of the operated elbow regardless of cause.
Measured: Recorded at 12 months after intervention.
Re-operation rate 36 months.
Total re-operation rate of the operated elbow regardless of cause.
Measured: Recorded at 36 months after intervention.
Secondary outcomes (21)
Complication rate 1.5 months.
Total complication rate.
Measured: Recorded at 1.5 months after intervention.
Complication rate 3 months.
Total complication rate.
Measured: Recorded at 3 months after intervention.
Complication rate 12 months.
Total complication rate.
Measured: Recorded at 12 months after intervention.
Complication rate 36 months.
Total complication rate.
Measured: Recorded at 36 months after intervention.
Complication severity 1.5 months.
Complication severity classified with the Clavien-Dindo Classification.
Measured: Recorded at 1.5 months after intervention.
Complication severity 3 months.
Complication severity classified with the Clavien-Dindo Classification.
Measured: Recorded at 3 months after intervention.
Complication severity 12 months.
Complication severity classified with the Clavien-Dindo Classification.
Measured: Recorded at 12 months after intervention.
Complication severity 36 months.
Complication severity classified with the Clavien-Dindo Classification.
Measured: Recorded at 36 months after intervention.
Quick-DASH 1.5 months.
Quick-DASH questionnaire assessed by subjects. See references PMID: 8773720 and 6709254.
Measured: 1.5 months after intervention.
Quick-DASH 3 months.
Quick-DASH questionnaire assessed by subjects. See references PMID: 8773720 and 6709254.
Measured: 3 months after intervention.
Quick-DASH 12 months.
Quick-DASH questionnaire assessed by subjects. See references PMID: 8773720 and 6709254.
Measured: 12 months after intervention.
Quick-DASH 36 months.
Quick-DASH questionnaire assessed by subjects. See references PMID: 8773720 and 6709254.
Measured: 36 months after intervention.
SMFA 12 months
SMFA-questionnaire assessed by subjects. See reference PMID: 27994082 and 14763711
Measured: 12 months after intervention.
Pain level 1.5 months.
Subjective pain level in motion and at rest. Measured with a visual analog scale.
Measured: Recorded at 1.5 months after intervention
Pain level 3 months.
Subjective pain level in motion and at rest. Measured with a visual analog scale.
Measured: Recorded at 3 months after intervention.
Pain level 12 months,
Subjective pain level in motion and at rest. Measured with a visual analog scale.
Measured: Recorded at 12 months after intervention.
Pain level 36 months.
Subjective pain level in motion and at rest. Measured with a visual analog scale.
Measured: Recorded at 36 months after intervention.
Overall satisfaction 1.5 months.
Subjective overall satisfaction level. Measured with a visual analog scale.
Measured: Recorded at 1.5 months after intervention.
Overall satisfaction 3 months.
Subjective overall satisfaction level. Measured with a visual analog scale.
Measured: Recorded at 3 months after intervention.
Overall satisfaction 12 months.
Subjective overall satisfaction level. Measured with a visual analog scale.
Measured: Recorded at 12 months after intervention.
Overall satisfaction 36 months.
Subjective overall satisfaction level. Measured with a visual analog scale.
Measured: Recorded at 36 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Jan 2023
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Olecranon 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Daniel Wenger, MD, PhD, Principal investigator, Department of Orthopedics, Skåne University Hospital and Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657899
- Sponsor's protocol ID
- DSF-220510-2038
- Acronym
- WOW-OK
- Status last verified
- Aug 2026
- First submitted
- 16 Nov 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wenger D, Cornefjord G, Rogmark C. Cerclage fixation without K-wires is associated with fewer complications and reoperations compared with tension band wiring in stable displaced olecranon fractures in elderly patients. Arch Orthop Trauma Surg. 2022 Oct;142(10):2669-2676. doi: 10.1007/s00402-021-04027-3. Epub 2021 Jul 8.
PubMed 34236459Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
PubMed 8773720Gries MW. Safety professional's role as health educator expanding. Occup Health Saf. 1984 Feb:42-3. No abstract available.
PubMed 6709254Williams N. The Short Musculoskeletal Function Assessment (SMFA) questionnaire. Occup Med (Lond). 2016 Dec;66(9):757. doi: 10.1093/occmed/kqw140. No abstract available.
PubMed 27994082Ponzer S, Skoog A, Bergstrom G. The Short Musculoskeletal Function Assessment Questionnaire (SMFA): cross-cultural adaptation, validity, reliability and responsiveness of the Swedish SMFA (SMFA-Swe). Acta Orthop Scand. 2003 Dec;74(6):756-63. doi: 10.1080/00016470310018324.
PubMed 14763711Cornefjord G, Kostogiannis I, Rogmark C, Jerrhag D, Wenger D. The With Or Without Olecranon K-wire (WOW OK) Trial of tension band wire fixation versus cerclage fixation without K-wires in displaced stable olecranon fractures: study protocol for a randomized controlled trial. Trials. 2023 Aug 29;24(1):559. doi: 10.1186/s13063-023-07566-9.
PubMed 37641082
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The With Or Without Olecranon K-wire (WOW OK) Trial of Tension Band Wire Fixation Versus Cerclage Fixation Without K-wires in Displaced Stable Olecranon Fractures
- ClinicalTrials.gov ID
- NCT05657899
- Acronym / sponsor ID
- WOW-OK / DSF-220510-2038
- Conditions
- Olecranon Fracture
- Keywords
- Tension Band Wiring, Cerclage, Surgery, Elbow injuries, Forearm injuries, Ulna fractures, Patient reported outcome measures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 20 Dec 2022 (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.
Fractures of the elbow tip (olecranon) that leave the elbow joint stable but where the fracture ends are separated (Mayo type 2a and 2b) can be treated with pins and a metal wire (tension band wiring, TBW) or metal wiring alone (cerclage fixation, CF ). Previous studies have reported high re-operation and complication rates following TBW. The current study's hypothesis, based on two retrospective studies, is that CF of these fractures yield lower re-operation rates compared with TBW. The investigators also hypothesize that the overall complication rate will be lower following CF. The aim is to investigate this hypothesis in a randomized controlled trial. Patients that are 18 years or older with Mayo type 2a and 2b olecranon fractures at Skåne University hospital will be invited to the study. Participation is voluntary. Patients who accept participation will be randomly assigned to surgery by either TBW or cerclage fixation. Two hundred participants will be followed by physiotherapists for 36 months post-surgery assessing re-operations, complications, patient reported outcome, and elbow function.
Detailed description
The complete study protocol including a detailed description of the trial will be published in a journal before the start of the trial.
Olecranon fractures account for approximately 20% of all proximal fractures of the forearm. Stable, undisplaced fractures (Mayo type 1a and 1b) are routinely treated non-operatively, while displaced and unstable fractures (Mayo type 3a and 3b) are typically operated with plate fixation. Stable, displaced fractures (Mayo type 2a and 2b) are often treated with tension band wiring (TBW) or plate fixation. TBW is associated with soft tissue irritation and high re-operation rates with hardware removal, ranging from 25% to 84% in the literature. Plate fixation was associated with fewer re-operations compared with TBW in a randomized controlled trial, but complications following plate fixation were more severe. A Cochrane review from 2014 did not find any significant support favouring either of the two methods. Non-operative treatment of Mayo type 2a and 2b fractures can yield acceptable results in elderly patients, but is not routinely used in younger individuals with higher functional demands. Two previous retrospective studies from 2002 and 2021 reported that Mayo 2a and 2b fractures can be operated with cerclage fixation alone yielding half the re-operation rates when compared to TBW. As of April 2022 there are two studies (one active (NCT03280602) and one completed (NCT01391936)) comparing TBW vs plate fixation, three studies (two active (NCT04670900 and NCT04401462) and one terminated (NCT01397643)) comparing non-operative vs operative treatment in elderly and one active study (NCT04189185) comparing TBW vs suture fixation registered on this site. The hypothesis of the current study is that the re-operation rate and the complication rate will be lower following CF compared with TBW while yielding equal results in other outcome measures. The aim is to to investigate this in a prospective randomized clinical trial.
Methodology:
All patients presenting at Skåne University Hospital in Malmö and Lund, Sweden, with olecranon fractures of Mayo type 2a and 2b will be invited to participate in the study if they do not meet any exclusion criteria. Potential subjects will be asked to sign a consent form after receiving written and oral information about the trial. Subjects will be randomized 1:1 to surgery with TBW or cerclage. 200 subjects will be recruited based on sample size calculations derived from the re-operation frequency in a previous study (PMID: 34236459)
Baseline descriptive data will be collected at inclusion or in the peri-operative period. Operation time, intra-operative effective radiation dose and radiation time will be recorded. Subjects will be invited to follow-up to a physiotherapist at 2 weeks, 6 weeks, 3 months, 12 months and 36 months after the operation assessing re-operations, complications, post-operative antibiotics, range of elbow motion, grip strength, the Quick Disabilities of the Arm, Shoulder and Hand score (Quick-DASH, references PMID: 8773720 and 6709254), overall patient satisfaction, pain, return to work and secondary dislocation. The Short Musculoskeletal Function Assessment (SMFA, references PMID: 27994082 and 14763711) score will be assessed 12 months post-operatively. The physiotherapist will be masked to the treatment method. At 6 months one radiograph will be collected for assessment of non-union.
The primary outcome measure will be re-operations. Secondary outcome measures will be patient reported outcome measures and complications. Tertiary outcome measures are post-operative range of motion and grip strength, secondary dislocation rate, time to return to work after surgery, operation time, effective intra-operative radiation dose and radiation time. The hypothesis of the current study is that cerclage fixation will yield less re-operations, less overall complications and less severe complications while other outcome measures will be equal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerclage | Active comparator | Procedure: Cerclage fixationIntervention by cerclage fixation. |
| Tension Band Wiring | Active comparator | Procedure: Tension band wiringIntervention by tension band wiring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sustained Olecranon type fracture of Mayo 2a or 2b
- Seeking healthcare in at the Skåne University Hospital in Lund and Malmö, Sweden.
Key exclusion criteria (9 listed)
- Subjects unable to participate in follow up (for example subjects with active substance abuse, dementia, inability to communicate or understand the questionnaires or subjects living in other administrative healthcare regions).
- Subjects unable to give informed written consent.
- Subject where non operative treatment is indicated due to frailty or severe ongoing disease.
- Fracture not operated within 14 days from the date the fracture was sustained.
- Subjects with severe open fractures of Gustilo-Anderson class III
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 |
|---|---|---|
| Cerclage fixationThe intervention is by surgical open reduction and internal fixation of the fracture using two 1.0mm cerclage. | Procedure or surgery | Cerclage |
| Tension band wiringThe intervention is by surgical open reduction and internal fixation of the fracture using a 1.0mm cerclage and two 1.6 mm k-wires as described in AO-guidelines. | Procedure or surgery | Tension Band Wiring |
Primary outcome
Re-operation rate 1.5 months.
Time frame: Recorded at 1.5 months after intervention.
Total re-operation rate of the operated elbow regardless of cause.
Re-operation rate 3 months.
Time frame: Recorded at 3 months after intervention.
Total re-operation rate of the operated elbow regardless of cause.
Re-operation rate 12 months.
Time frame: Recorded at 12 months after intervention.
Total re-operation rate of the operated elbow regardless of cause.
Re-operation rate 36 months.
Time frame: Recorded at 36 months after intervention.
Total re-operation rate of the operated elbow regardless of cause.
21 secondary outcomes
Complication rate 1.5 months.
Time frame: Recorded at 1.5 months after intervention.
Complication rate 3 months.
Time frame: Recorded at 3 months after intervention.
Complication rate 12 months.
Time frame: Recorded at 12 months after intervention.
Complication rate 36 months.
Time frame: Recorded at 36 months after intervention.
Complication severity 1.5 months.
Time frame: Recorded at 1.5 months after intervention.
Complication severity 3 months.
Time frame: Recorded at 3 months after intervention.
Complication severity 12 months.
Time frame: Recorded at 12 months after intervention.
Complication severity 36 months.
Time frame: Recorded at 36 months after intervention.
Quick-DASH 1.5 months.
Time frame: 1.5 months after intervention.
Quick-DASH 3 months.
Time frame: 3 months after intervention.
Quick-DASH 12 months.
Time frame: 12 months after intervention.
Quick-DASH 36 months.
Time frame: 36 months after intervention.
SMFA 12 months
Time frame: 12 months after intervention.
Pain level 1.5 months.
Time frame: Recorded at 1.5 months after intervention
Pain level 3 months.
Time frame: Recorded at 3 months after intervention.
Pain level 12 months,
Time frame: Recorded at 12 months after intervention.
Pain level 36 months.
Time frame: Recorded at 36 months after intervention.
Overall satisfaction 1.5 months.
Time frame: Recorded at 1.5 months after intervention.
Overall satisfaction 3 months.
Time frame: Recorded at 3 months after intervention.
Overall satisfaction 12 months.
Time frame: Recorded at 12 months after intervention.
Overall satisfaction 36 months.
Time frame: Recorded at 36 months after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 34236459Wenger D, Cornefjord G, Rogmark C. Cerclage fixation without K-wires is associated with fewer complications and reoperations compared with tension band wiring in stable displaced olecranon fractures in elderly patients. Arch Orthop Trauma Surg. 2022 Oct;142(10):2669-2676. doi: 10.1007/s00402-021-04027-3. Epub 2021 Jul 8.
- Background: PubMed 8773720Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
- Background: PubMed 6709254Gries MW. Safety professional's role as health educator expanding. Occup Health Saf. 1984 Feb:42-3. No abstract available.
- Background: PubMed 27994082Williams N. The Short Musculoskeletal Function Assessment (SMFA) questionnaire. Occup Med (Lond). 2016 Dec;66(9):757. doi: 10.1093/occmed/kqw140. No abstract available.
- Background: PubMed 14763711Ponzer S, Skoog A, Bergstrom G. The Short Musculoskeletal Function Assessment Questionnaire (SMFA): cross-cultural adaptation, validity, reliability and responsiveness of the Swedish SMFA (SMFA-Swe). Acta Orthop Scand. 2003 Dec;74(6):756-63. doi: 10.1080/00016470310018324.
- Derived from this study: PubMed 37641082Cornefjord G, Kostogiannis I, Rogmark C, Jerrhag D, Wenger D. The With Or Without Olecranon K-wire (WOW OK) Trial of tension band wire fixation versus cerclage fixation without K-wires in displaced stable olecranon fractures: study protocol for a randomized controlled trial. Trials. 2023 Aug 29;24(1):559. doi: 10.1186/s13063-023-07566-9.
- 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.
Daniel Wenger, MD, PhD principal investigator
Department of Orthopedics, Skåne University Hospital and Lund University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerclage fixation and Tension band wiring in people with Olecranon Fracture, run by Region Skane at 2 sites in Sweden.
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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Wenger, MD, PhD (+46 73-815 15 50, daniel.wenger@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-operation rate 1.5 months. (time frame: Recorded at 1.5 months after intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657899, which also lists 6 linked publications.
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 1 Sep 2026.