Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary NailNCT05173181
Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
A study testing Flexible intramedullary nail in people with Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail, run by Sohag University at 1 site in Egypt.
Trial summary
The distal ulna is an important weight-bearing component of the wrist joint and an essential element of the forearm articulation. After injury, significant residual malalignment or deformity of the distal ulna and deficiency of its ligamentous support have a deleterious effect on grip strength and forearm rotation. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
- What is being tested?
- Flexible intramedullary nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2021to 30 Jul 2022
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with displaced distal ulna fractures in adult patient admitted in orthopaedic department of Sohag University Hospital after taking an informed consent from patients or near relatives
Who cannot join
- Patients with Intra articular fractures
- Fractures with disturbed radioulnar joint
- Old malunited or deformed distal ulna
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, 82515
Elshazly Mosa, Professor of Orthopaedics
About this study
The distal ulna is an important weight-bearing component of the wrist joint and an essential element of the forearm articulation. After injury, significant residual malalignment or deformity of the distal ulna and deficiency of its ligamentous support have a deleterious effect on grip strength and forearm rotation.
Although the best treatment option for displaced distal ulnar fracture remains a subject of debate, most surgeons aim for anatomical reduction and stable fixation to avoid disruption of the distal radioulnar joint.
The investigators will assess clinical and radiological results of fixation of displaced distal ulna fractures in adults by flexible intramedullary nail.
Read the detailed description
The distal ulna is an important weight-bearing component of the wrist joint and an essential element of the forearm articulation. After injury, significant residual malalignment or deformity of the distal ulna and deficiency of its ligamentous support have a deleterious effect on grip strength and forearm rotation.
Fractures of the distal ulna usually occur in association with distal radius fractures.
Isolated distal ulnar fracture is an uncommon upper limb injury. It is usually the consequence of a direct blow against the soft tissue-deficient ulnar border.
Injuries to the distal ulna can lead to derangement of the distal radioulnar joint (DRUJ), subsequently resulting in pain from incongruity or ulnocarpal impaction, limitation of forearm rotation due to scarring, and weakness secondary to instability of the joint under load.
Isolated fractures of the distal third of the ulnar shaft can be treated successfully by conservative if not significantly displaced and if rotational malalignment is not present. Fractures with significant displacement or those with rotational malalignment (displaced spiral fracture patterns) are best be treated by osteosynthesis and functional rehabilitation in order to prevent loss of forearm rotation.
Although the best treatment option for displaced distal ulnar fracture remains a subject of debate, most surgeons aim for anatomical reduction and stable fixation to avoid disruption of the distal radioulnar joint.
The investigators aim is to assess clinical and radiological results of fixation of displaced distal ulna fractures in adults by flexible intramedullary nail.
It is a prospective study patients with displaced distal ulna fractures in adult patient admitted in orthopaedic department of Sohag University Hospital after taking an informed consent from patients or near relatives. Fractures will be managed using flexible intra medullary nail .
Patients with Intra articular fractures , Fractures with disturbed radioulnar joint , or Old malunited or deformed distal ulna are excluded.
- Clinical evaluation of patient by Grace and Eversmann rating system used to assess functional evaluation ,VAS (visual analogue scale),or Dash score (Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores).
- Radiological evaluation as plain x ray.
Time plan : clinical and radiolodical evaluation as follow:
- Immediately postoperative.
- 2 weeks postoperative.
- 1month postoperative.
- 2 months postoperative.
- 6 months postoperative.
- Being tested
- Flexible intramedullary nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible intramedullary nailDevice
Fixation of distal ulna fracture with flexible intramedullary nail
| Study group | Role | What they receive |
|---|---|---|
| Adult with fracture distal ulna | Other | Not described Receives: Device: Flexible intramedullary nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological evaluation
Displacement of fracture - signs of healing
Measured: Immediately postoperative
Grace and Eversmann rating system
Rating system that was based only on fracture union and pronation-supination of the forearm. Motion of the wrist and elbow was not used in the rating system, 10 means excellent results 4 means acceptable results.
Measured: 6 months postoperative
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores
Self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100
Measured: 6 months postoperative
Radiological evaluation
Displacement of fracture - signs of healing
Measured: 2 weeks postoperative
Radiological evaluation
Displacement of fracture - signs of healing
Measured: 1month postoperative
Radiological evaluation
Displacement of fracture - signs of healing
Measured: 2 months postoperative
Radiological evaluation
Displacement of fracture - signs of healing
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start25 Nov 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary NailStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators have only one group of patients, (Adult with isolated fracture distal ulna). The investigators will do a single intervention, (Fixation with flexible intramedullary nail).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hassan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173181
- Sponsor's protocol ID
- Soh-Med-21-11-08
- Status last verified
- Dec 2021
- First submitted
- 27 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Publications
Grace TG, Eversmann WW Jr. Forearm fractures: treatment by rigid fixation with early motion. J Bone Joint Surg Am. 1980 Apr;62(3):433-8.
PubMed 7364814Matthews LS, Kaufer H, Garver DF, Sonstegard DA. The effect on supination-pronation of angular malalignment of fractures of both bones of the forearm. J Bone Joint Surg Am. 1982 Jan;64(1):14-7.
PubMed 7054197PATRICK J. A study of supination and pronation, with especial reference to the treatment of forearm fractures. J Bone Joint Surg Am. 1946 Oct;28(4):737-48. No abstract available.
PubMed 21003183
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
- ClinicalTrials.gov ID
- NCT05173181
- Acronym / sponsor ID
- Soh-Med-21-11-08
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 29 Dec 2021 (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.
The distal ulna is an important weight-bearing component of the wrist joint and an essential element of the forearm articulation. After injury, significant residual malalignment or deformity of the distal ulna and deficiency of its ligamentous support have a deleterious effect on grip strength and forearm rotation.
Although the best treatment option for displaced distal ulnar fracture remains a subject of debate, most surgeons aim for anatomical reduction and stable fixation to avoid disruption of the distal radioulnar joint.
The investigators will assess clinical and radiological results of fixation of displaced distal ulna fractures in adults by flexible intramedullary nail.
Detailed description
The distal ulna is an important weight-bearing component of the wrist joint and an essential element of the forearm articulation. After injury, significant residual malalignment or deformity of the distal ulna and deficiency of its ligamentous support have a deleterious effect on grip strength and forearm rotation.
Fractures of the distal ulna usually occur in association with distal radius fractures.
Isolated distal ulnar fracture is an uncommon upper limb injury. It is usually the consequence of a direct blow against the soft tissue-deficient ulnar border.
Injuries to the distal ulna can lead to derangement of the distal radioulnar joint (DRUJ), subsequently resulting in pain from incongruity or ulnocarpal impaction, limitation of forearm rotation due to scarring, and weakness secondary to instability of the joint under load.
Isolated fractures of the distal third of the ulnar shaft can be treated successfully by conservative if not significantly displaced and if rotational malalignment is not present. Fractures with significant displacement or those with rotational malalignment (displaced spiral fracture patterns) are best be treated by osteosynthesis and functional rehabilitation in order to prevent loss of forearm rotation.
Although the best treatment option for displaced distal ulnar fracture remains a subject of debate, most surgeons aim for anatomical reduction and stable fixation to avoid disruption of the distal radioulnar joint.
The investigators aim is to assess clinical and radiological results of fixation of displaced distal ulna fractures in adults by flexible intramedullary nail.
It is a prospective study patients with displaced distal ulna fractures in adult patient admitted in orthopaedic department of Sohag University Hospital after taking an informed consent from patients or near relatives. Fractures will be managed using flexible intra medullary nail .
Patients with Intra articular fractures , Fractures with disturbed radioulnar joint , or Old malunited or deformed distal ulna are excluded.
- Clinical evaluation of patient by Grace and Eversmann rating system used to assess functional evaluation ,VAS (visual analogue scale),or Dash score (Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores).
- Radiological evaluation as plain x ray.
Time plan : clinical and radiolodical evaluation as follow:
- Immediately postoperative.
- 2 weeks postoperative.
- 1month postoperative.
- 2 months postoperative.
- 6 months postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators have only one group of patients, (Adult with isolated fracture distal ulna). The investigators will do a single intervention, (Fixation with flexible intramedullary nail).
| Arm | Type | Receives |
|---|---|---|
| Adult with fracture distal ulna | Other | Device: Flexible intramedullary nail |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with displaced distal ulna fractures in adult patient admitted in orthopaedic department of Sohag University Hospital after taking an informed consent from patients or near relatives
Key exclusion criteria (3 listed)
- Patients with Intra articular fractures
- Fractures with disturbed radioulnar joint
- Old malunited or deformed distal ulna
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 |
|---|---|---|
| Flexible intramedullary nailFixation of distal ulna fracture with flexible intramedullary nail | Device | Adult with fracture distal ulna |
Primary outcome
Radiological evaluation
Time frame: Immediately postoperative
Displacement of fracture - signs of healing
Grace and Eversmann rating system
Time frame: 6 months postoperative
Rating system that was based only on fracture union and pronation-supination of the forearm. Motion of the wrist and elbow was not used in the rating system, 10 means excellent results 4 means acceptable results.
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores
Time frame: 6 months postoperative
Self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100
Radiological evaluation
Time frame: 2 weeks postoperative
Displacement of fracture - signs of healing
Radiological evaluation
Time frame: 1month postoperative
Displacement of fracture - signs of healing
Radiological evaluation
Time frame: 2 months postoperative
Displacement of fracture - signs of healing
Radiological evaluation
Time frame: 6 months postoperative
Displacement of fracture - signs of healing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Results publication: PubMed 7364814Grace TG, Eversmann WW Jr. Forearm fractures: treatment by rigid fixation with early motion. J Bone Joint Surg Am. 1980 Apr;62(3):433-8.
- Results publication: PubMed 7054197Matthews LS, Kaufer H, Garver DF, Sonstegard DA. The effect on supination-pronation of angular malalignment of fractures of both bones of the forearm. J Bone Joint Surg Am. 1982 Jan;64(1):14-7.
- Results publication: PubMed 21003183PATRICK J. A study of supination and pronation, with especial reference to the treatment of forearm fractures. J Bone Joint Surg Am. 1946 Oct;28(4):737-48. No abstract available.
- Individual participant dataSharing planned: Undecided. Not decided yet
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible intramedullary nail in people with Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Hassan, Elsayed (00201009680600, orthopedicman600@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological evaluation (time frame: Immediately postoperative). The study lists 7 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 NCT05173181, which also lists 3 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 29 Dec 2021.