Compared to the Allis technique, the Captain Morgan technique is more effective in reduction of posterior dislocations of total hip prostheses using procedural sedation and anesthesia in the emergency room
ID
Bron
Verkorte titel
Aandoening
Posterior disclocation of total hip prosthesis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Total percentage of successfull reduction.
Achtergrond van het onderzoek
Rationale: 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.
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.
Study population: Patients, aged ≥ 18 y.o., presenting in the ER with unilateral dislocation of a THP.
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.
Main study endpoint: Total percentage of successful reduction per respective technique.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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).
Doel van het onderzoek
Compared to the Allis technique, the Captain Morgan technique is more effective in reduction of posterior dislocations of total hip prostheses using procedural sedation and anesthesia in the emergency room
Onderzoeksopzet
All data will be collected during a subject's stay in the emergency department. No follow-up.
Onderzoeksproduct en/of interventie
In one group, the Captain Morgan technique will be used to reduce the hip, in the other group the Allis technique will be used.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Unilateral posterior dislocation of a total hip prosthesis
- Age ≥ 18 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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).
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8423 |
| Ander register | RPTO MCL : RTPO1086 |