|- candidate number||28176|
|- NTR Number||NTR6810|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-nov-2017|
|- Secondary IDs||2016-015 |
|- Public Title||Force measurements during hip arthroscopy|
|- Scientific Title||The relation between traction and the displacement of caput femur during hip arthroscopy|
|- Healt Condition(s) or Problem(s) studied||Hip arthroscopy|
|- Inclusion criteria||Patients who:|
- are 15-65 years of age.
- Have a physical examination, which is suspect for femoroacetabular impingement, or an acetabulum labrum tear or lesion, or are suspect to loose bodies in the hip joint, chondral lesions or osteophytes impingement.
- Patients smaller then 1,74 m.
|- Exclusion criteria||Patients who:|
- are <15 or >65 years of age.
- Have had prior surgery for femoroacetabular impingement.
- Have pathological fractures or other metastatic pathology as a cause of the hip/groin pain.
- Patients taller then 1,74 m.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||28-apr-2016|
|- planned closingdate||1-jan-2018|
|- Target number of participants||28|
|- Interventions||Force measurements during hip arthroscopy|
|- Primary outcome||The main study outcome is the relation between the pulling force, needed to dislocate the hip and the displacement of the femoral and acetabular component of the hip.|
|- Secondary outcome||not applicable|
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| N.M.C. Mathijssen|
|- CONTACT for SCIENTIFIC QUERIES||dr. N.M.C. Mathijssen|
|- Sponsor/Initiator ||Reinier de Graaf Groep, Department of Orthopaedics|
(Source(s) of Monetary or Material Support)
|Reinier de Graaf Groep, Department of Orthopaedics|
|- Brief summary||Introduction: |
Hip arthroscopy is a relatively new surgical technique with expanding intervention options and growing possibilities. The main indications for arthroscopic intervention are femoroacetabular impingement (FAI). During hip arthroscopy the patient is placed in a hip distractor system. With this system traction is applied to dislocate the hip. The pulling force which is necessary to dislocate the caput femur is unknown, and it is unknown if there is a relation between the pulling and the absolute displacement.
The primary objective of this prospective cohort study is to describe a relation between the pulling force and the absolute displacement of the caput femur.
A prospective cohort study during hip arthroscopies in Reinier de Graaf Gasthuis Hospital in Delft will be conducted. All consecutive patients who will have hip arthroscopy in our hospital will be asked to participate.
Patients, male and female, with specific hip pain, derived from the outpatient clinic in Reinier de Graaf Gasthuis Delft, department of Orthopedic surgery will be asked to participate.
All patients will be operated by one orthopaedic surgeon (RB), with large experience in hip arthroscopy. The operation is performed by standardized operation protocol.
Main endpoint is the relation between the pulling force, needed to dislocate the hip and the displacement of the femoral and acetabular component of the hip. It is unknown how much force is needed to dislocate the hip over a certain distance. Therefore this study will be performed. A dynamometer will be placed in the hip distractor system, to measure the force. Next to the patient a calibrated piece of metal (calibrated to measure dimensions on an x-ray) will be placed next to the hip, at the same height of the caput femur, to measure the joint space afterwards on an x-ray.
Data will be presented quantitative by continuous variables (force). The correlation between force and displacement will be tested with Pearsonís correlation (if data is normally distributed) or with Spearmanís rho.
|- Main changes (audit trail)|
|- RECORD||10-nov-2017 - 17-mrt-2018|