The goal of this study is to directly compare effectiveness of the Captain Morgan technique to the Allis technique in reduction of posterior dislocation of a THP using procedural sedation and analgesia (PSA) in the ER.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total percentage of successful reduction per respective technique.
Secondary outcome
- Percentage of successfull reductions subdivided by experience of the
physician.
- Percentage of successfull reducctions subdivided by amount of dislocation.
- Percentage of successfull reductions subdivided by number of previous
dislocations (e.g. first versus repeat episode)
Background summary
Dislocation of a total hip prosthesis (THP) is a frequent reason for admission
to the emergency room (ER). Despite many describes and applied reduction
techniques, available literature regarding their effectiveness is surprisingly
limited. No direct comparisons of different techniques are described. The
largest study regarded the Allis technique. In a small study, the relatively
new Captain Morgan technique was found to be considerably more effective. Also,
it is associated with less potential health risks for the treating physician.
Study objective
The goal of this study is to directly compare effectiveness of the Captain
Morgan technique to the Allis technique in reduction of posterior dislocation
of a THP using procedural sedation and analgesia (PSA) in the ER.
Study design
Multicenter prospective randomized cohort study.
Intervention
In one group, the Captain Morgan technique will be used to reduce the hip, in
the other group the Allis technique will be used.
Study burden and risks
All treatment aspects used in this study are part of the standard care for the
condition. Thus, no additional risks are involved. The only addition to
standard care is a request to written informed consent. Participation provides
subjects no direct benefits. However, subjects do contribute to future
treatment of the condition (considering the sometimes recurrent nature of the
condition, they might end up benefitting themselves at a later point in
time).
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
- Unilateral posterior dislocation of a total hip prosthesis
- Age >= 18 years.
Exclusion criteria
- Concomittant traumatic findings that complicate reduction or are of greater
urgency (e.g. (periprosthetic) fractures of the involved leg of
life-threatening injury requering immediate intervention)
- Previously >1 unsuccesfull reducation despite optimal circumstances (a.o.
adequate sedation and procedural analgesia).
- No informed consent or refusal of treatment.
- Other reason to perform reduction in the operating room (logistics,
personnel).
- Hip prosthesis with a dual mobility cup (these always require reduction in
the operating room).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | NL 8423 (www.trialregister.nl) |
| CCMO | NL71705.099.19 |