Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications
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|ClinicalTrials.gov Identifier: NCT01959360|
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : May 15, 2019
The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications.
The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by two minimal invasive/incision surgeries (MIS) versus the traditionally lateral approach.
The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after MIS than after traditional lateral surgery. Patients in the MIS group will also be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.
|Condition or disease||Intervention/treatment||Phase|
|Hip Osteoarthritis||Procedure: Direct lateral Procedure: minimal invasive Procedure: modified minimal invasive||Not Applicable|
With total hip replacement surgery, the orthopaedic surgeon's aim is not only pain relief for the patient, but also restoration of hip joint biomechanics resulting in a minimal functional deficit and maximal longevity of the implant. It is not exceptional that these patients still experience mild to moderate long-term impairments postoperatively. These impairments include pain, muscle weakness of the hip abductors, contracture of the hip, gait disorders, as well as weakness of hip extensors and flexors. These problems may in turn lead to complications such as joint instability and loosening of the implant. When the lateral surgical approach is used, major concerns after total hip replacement surgery are muscle abductor weakness/atrophy, tendon defects of the gluteus minimus muscle, and unsuccessful reattachment or denervation of the anterior gluteal flap.
Minimal incision/invasive surgery (MIS) is defined as a surgical approach performed through a short skin and muscle incision to avoid injury to muscles and tendons. Following minimally invasive approach reduced muscle trauma has been found. Moreover clinical outcome improved, as the gluteus medius muscle can be spared more successfully. However, it is debated whether or not the overall results of MIS are superior, or even as good as the traditional hip replacement surgery in terms of component placing and time to revision of the prosthesis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications|
|Actual Study Start Date :||August 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2018|
|Active Comparator: direct lateral||
Procedure: Direct lateral
Total hip replacement; direct lateral approach
|Experimental: minimal invasive||
Procedure: minimal invasive
Total hip replacement; minimal invasive approach
|Experimental: modified minimal invasive||
Procedure: modified minimal invasive
Total hip replacement; modified minimal invasive approach
- Implant stability [ Time Frame: 2 years ]
- Implant stability [ Time Frame: 5 years ]
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): NCT01959360
|St Olavs Hospital|
|Study Director:||Lars Jacob Stovner, prof||Norwegian University of Science and Technology|