Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results
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Purpose
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 | Intervention |
|---|---|
|
Hip Osteoarthritis |
Procedure: Total hip replacement |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results |
- Abductor muscle strength [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]Measured by 1 repetition maximum (1 RM)
- Hip joint functionality and mobility [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]Measured by patient completed questionnaires and clinician reported scores
- activity level [ Time Frame: 6 subsequent days postoperatively ] [ Designated as safety issue: No ]Measured by an activity monitor
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Direct lateral |
Procedure: Total hip replacement
Total hip replacement; direct lateral approach
|
| Experimental: Minimal invasive |
Procedure: Total hip replacement
Total hip replacement; minimal invasive approach
|
| Experimental: Modified minimal invasive |
Procedure: Total hip replacement
Total hip replacement; modified minimal invasive approach
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients scheduled for THA
- Diagnosis of primary osteoarthritis as the main cause for elective THA
- American Society of Anesthesiologists (ASA) score I, II, and stable III
Exclusion Criteria:
- Musculoskeletal diseases
- Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.
Contacts and Locations| Contact: Siri Bjørgen, PhD | +47 72573669 | siri.bjorgen@ntnu.no |
| Norway | |
| St. Olavs Hospital | Recruiting |
| Trondheim, Norway | |
| Contact: Siri Bjørgen, PhD siri.bjorgen@ntnu.no | |
| Principal Investigator: Siri Bjørgen, PhD | |
| Principal Investigator: | Siri Bjørgen, PhD | Norwegian University of Science and Technology |
More Information
No publications provided
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01506024 History of Changes |
| Other Study ID Numbers: | 2011/450 |
| Study First Received: | December 9, 2011 |
| Last Updated: | January 4, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Norwegian University of Science and Technology:
|
Arthroplasty, Replacement, Hip Surgical Procedures, Operative Surgical Procedures, Minimally Invasive |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Hip Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013