Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02996383|
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : December 19, 2016
In England each year over 70,000 people fracture their hip. Most of these patients are elderly females with the fracture occurring after a simple trip or stumble. Approximately half of these fractures are classified from their relationship to the hip joint capsule as intracapsular. These fractures are subdivided into those that are displaced and those that are undisplaced. The majority of displaced fractures are treated with a replacement arthroplasty. Current treatment for the undisplaced fractures is generally by internal fixation of the fracture using screws and a plate, although some centres prefer replacement arthroplasty.
A recent randomised study on patients from Norway with undisplaced intracapsular fractures treated with either internal fixation or arthroplasty has just reported reduced complications and re-operations for those patients treated with an arthroplasty. In addition functional results were marginally better for those patients treated with an arthroplasty. Current practice in the UK is generally to treat these fractures by internal fixation. This study aims to see if replacement arthroplasty can indeed lead to the advantages suggested from the Norwegian study.
Patients who satisfy the inclusion criteria and are willing to participate will be randomised to receive either reduction and internal fixation of the fracture with a screw and plate device or alternatively replacement of their femoral head with an artificial hip replacement (hemiarthroplasty). After surgery patients will receive the same treatment as normal and be discharge home when able, with follow-up review in the hip fracture clinic. Subsequent follow-up for the research project is by phone calls from a research nurse who is blinded to the type of treatment that the patient has received. There will be no additional investigations or out-patient follow-up visits for these patients in comparison to normal treatment protocols. Results of the study will ultimately be published in a medical journal.
|Condition or disease||Intervention/treatment||Phase|
|Hip Fractures Undisplaced Intracapsular Hip Fracture||Device: Internal fixation Device: Cemented Hemiarthroplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||September 2019|
Active Comparator: Cemented hemiarthroplasty
Treatment of the fracture by a replacement arthroplasty with a cemented CPT hemiarthroplasty (manafactured by Zimmer company, Warsaw IN, USA) inserted via an anteriolateral approach to the hip
Device: Cemented Hemiarthroplasty
Replacement of the femoral head with a cemented hemiarthroplasty
Active Comparator: Internal fixation
Internal fixation of the fracture with a screw and plate device (Targon FN plate, Aesculap cooperation, Tuttingham, Germany)
Device: Internal fixation
Internal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany)
- regain of mobility using the Parker and Palmer mobility scale [ Time Frame: one year ]Assessment is using the Parker and Palmer mobility score (Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993;75:797-8.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996383
|Contact: martyn email@example.com|
|Peterborough and Stamford Hospital NHS Foundation Trust||Recruiting|
|Peterborough, Cambs, United Kingdom, PE36DA|
|Contact: Martyn J Parker, MD 441733874000 ext 4193 Martyn.Parker@pbh-tr.nhs.uk|