Clinical trial NCT05173181: Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
Official title: Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with Intra articular fractures
* Fractures with disturbed radioulnar joint
* Old malunited or deformed distal ulna

Primary outcomes:
measure: Radiological evaluation
timeFrame: Immediately postoperative
measure: Grace and Eversmann rating system
timeFrame: 6 months postoperative
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores
timeFrame: 6 months postoperative
measure: Radiological evaluation
timeFrame: 2 weeks postoperative
measure: Radiological evaluation
timeFrame: 1month postoperative
measure: Radiological evaluation
timeFrame: 2 months postoperative
measure: Radiological evaluation
timeFrame: 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
citation: Matthews 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.
citation: PATRICK 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.