|- candidate number||28018|
|- NTR Number||NTR6883|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-okt-2017|
|- Secondary IDs||NL63397.044.17 |
|- Public Title||Pilot study into the working mechanism of a brace preventing hip displacement after total hip replacement surgery|
|- Scientific Title||Pilot study into the biomechanical working mechanisms of a brace that aims to prevent hip dislocation after total hip replacement surgery|
|- hypothesis||The brace is able to restrict the movement that pose a risk for hip displacement after total hip replacement surgery|
|- Healt Condition(s) or Problem(s) studied||Total hip replacement (THR), Hip dislocation|
|- Inclusion criteria||- Aged 18 and above.|
- No musculoskeletal problems influencing walking ability and range of motion of the hip. To objectify the musculoskeletal problems, the primary investigator will go through a questionnaire (‘Vragenlijst Orthopedische Problemen’ ) together with the participant. In addition, the primary investigator who has a background in physical therapy will assess the hip range of motion to see whether participants are able to make the movements that pose a risk for hip dislocation (>90 hip flexion, adduction and rotations).
- Be able to be physically (low-intensity) active for a period of 4 hours.
|- Exclusion criteria||- Had a joint replacement surgery of one of the joints of the lower extremities.|
- Not able to understand Dutch or English instructions.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-nov-2017|
|- planned closingdate||31-okt-2018|
|- Target number of participants||10|
|- Interventions||Prescription of a brace that prevents hip displacement after total hip replacement surgery.|
|- Primary outcome||Peak hip anteflexion, adduction, endoratation and exorotation during several functional activities.|
|- Secondary outcome||Peak joint angles of the knee and ankle of the ipsilateral leg and joint angles of the joints of the contralateral leg. |
|- Timepoints||Single measurement|
|- Trial web site||NA|
|- CONTACT FOR PUBLIC QUERIES|| Erik Prinsen|
|- CONTACT for SCIENTIFIC QUERIES|| Erik Prinsen|
|- Sponsor/Initiator ||Roessingh Research and Development|
(Source(s) of Monetary or Material Support)
|- Brief summary||Preventing hip dislocation is an important part of the postoperative care after total hip replacement. Hip dislocation is associated with implant failure and it may lead to recurrent hip dislocations. One of the possible interventions to prevent hip dislocation is the prescription of a brace, such as the Rebound Hip brace, that restricts the movements that are associated with hip dislocations. While these braces are prescribed in daily care there is little scientific knowledge about the efficacy of these braces in preventing movements that might lead to a hip displacement. |
In this trial we exam whether a brace preventing hip displacement restricts the movements that pose a risk for hip displacement in a group of healthy adults.
The subjects will perform a set of measurements consisting of different activities of daily living both with and without the brace. After completion of the measurements, the brace will be removed and subjects will leave the study.
The main study parameters are the peak hip flexion, adduction and rotation angles during the execution of the different tasks. In addition, we will study the peak angles of the other joints to see whether the brace influences the movements of these joints.
|- Main changes (audit trail)|
|- RECORD||15-okt-2017 - 27-dec-2017|