Primary objective:To study the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) scores, reflecting functional outcome and pain in patients who sustained a complex elbow dislocation and were treated with ORIF and/or arthroplasty and a hinged…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) score
Secondary outcome
Mayo elbow performance index (MEPI)
Oxford Elbow Score
Pain level at both sides (VAS)
Range of motion at both sides
Radiographic healing of the fractures
Rate of secondary interventions
Rate of complications
Health-related quality of life (Short Form-36; SF-36)
Background summary
The elbow joint is the second most commonly dislocated joint in adults. The
annual incidence of elbow dislocations is 6.1 per 100.000. Complex dislocations
of the elbow are associated with fractures. The majority of elbow fractures in
adults involves the radial head (30%), the olecranon process (20%), or the
coronoid process (10-15%).
The fundamental goal in the management of fracture dislocation of the
elbow is the restoration of the osseous-articular restraints. Therefore, the
majority of these complex dislocations is treated with open reposition and
internal fixation (ORIF) and/or arthroplasty. Due to ligament disruption,
complex elbow dislocations are at risk of persistent instability if not treated
adequately. The current postoperative management of instable elbows following
ORIF and/or arthroplasty consists of primary ligament repair and/or a period of
plaster immobilization.
A period of plaster immobilization after ORIF may result in a limited
range of motion of the elbow joint with subsequent stiffness and (major)
disability. A hinged external elbow fixator, on the other hand, may provide
enough stability to start early mobilization after surgery. This may
potentially limit future disability due to restricted motion.
Study objective
Primary objective:
To study the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) scores,
reflecting functional outcome and pain in patients who sustained a complex
elbow dislocation and were treated with ORIF and/or arthroplasty and a hinged
external fixator.
Secondary objectives:
1. To examine the Mayo elbow performance index (MEPI) in patients who were
treated with ORIF and/or arthroplasty and an hinged external fixator after a
complex elbow dislocation
2. To examine the Oxford Elbow Score in patients who were treated with ORIF
and/or arthroplasty and an hinged external fixator after a complex elbow
dislocation
3. To determine the level of pain (recorded using a Visual Analogue Scale; VAS)
experienced by the patients who were treated with ORIF and/or arthroplasty and
an hinged external fixator after a complex elbow dislocation
4. To determine the range of motion of the elbow joint in patients who were
treated with ORIF and/or arthroplasty and an hinged external fixator after a
complex elbow dislocation
5. To determine the rate of secondary interventions and other postoperative
complications (i.e., reluxations, instability, heterotopic ossifications,
infections, bleeding, venous thrombosis and neurological deficit) in patients
who were treated with ORIF and/or arthroplasty and an hinged external fixator
after a complex elbow dislocation
6. To determine the time to radiographic healing in patients who were treated
with ORIF and/or arthroplasty and an hinged external fixator after a complex
elbow dislocation
7. To determine the health-related quality of life (Short Form-36, SF-36) in
patients who were treated with ORIF and/or arthroplasty and an hinged external
fixator after a complex elbow dislocation
Study design
Multicenter cohort study
Intervention
Hinged external elbow fixator
Study burden and risks
The intervention is a standard of care treatment modality.
The clinic follow-up visits at t=2 and 6 weeks, and 3, 6, and 12 months are
part of Standard of Care.
The same holds true for the X-rays at t=2 and 6 weeks, and 3, 6, and 12 months,
and the pre-operative X-ray or CT-scan
(for diagnosis).
Patients are asked to complete a set of questionnaires at the clinic FU visits
mentioned. There are no risks involved in this.
's-Gravendijkwal 230
3015 CE Rotterdam
NL
's-Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients meeting the following inclusion criteria are eligible for enrolment:
1. Men or women aged 18 years and older (with no upper age limit)
2. Patient with a complex elbow dislocation (i.e., dislocation of the elbow joint, combined with at least a fracture of the radial head, coronoid process, or olecranon)
3. Patient was treated with a hinged external fixator after ORIF and/or arthroplasty due to persistent instability
4. Provision of informed consent by patient
Exclusion criteria
If any of the following criteria applies, patients will be excluded:
1. Patients with distal intra-articular humeral fractures
2. Patients with additional traumatic injuries of the affected upper limb
3. Patients who underwent repair of the collateral ligaments
4. Patients with an impaired elbow function (i.e., stiff or painful elbow or neurological disorder of the upper limb) prior to the injury
5. Retained hardware around the affected elbow
6. Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., patients with no fixed address will be excluded)
7. Insufficient comprehension of the Dutch language to understand the rehabilitation program and other treatment information in the judgment of the attending physician
Exclusion of a patient because of enrolment in another ongoing drug or surgical intervention trial will be left to the discretion of the attending surgeon, on a case-by-case basis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL28503.078.09 |
| OMON | NL-OMON23505 |