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Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Total hip arthroplasty direct lateral approach
Total hip arthroplasty posterior approach
Total hip arthroplasty, anterior approach
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Arthroplasty, Replacement, Hip, Surgical Procedures, Operative, Surgical Procedures, Minimally Invasive

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

THA Direct lateral

THA Posterior

THA Anterior

Arm Description

Total hip arthroplasty (THA) carried out by direct lateral approach (DLA)

Total hip arthroplasty (THA) carried out by posterior approach (DLA)

Total hip arthroplasty (THA) carried out by anterior approach (DLA)

Outcomes

Primary Outcome Measures

Muscle strength
Measured by 1 repetition maximum (1 RM)

Secondary Outcome Measures

Hip joint functionality and mobility
Measured by patient completed questionnaires and clinician reported scores
activity level
Measured by an activity monitor

Full Information

First Posted
December 9, 2011
Last Updated
November 14, 2018
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01506024
Brief Title
Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results
Official Title
Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 the direct lateral approach (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS). 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 the AA than the PA and the DLA. Patients in the AA group are also thought to be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Arthroplasty, Replacement, Hip, Surgical Procedures, Operative, Surgical Procedures, Minimally Invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THA Direct lateral
Arm Type
Active Comparator
Arm Description
Total hip arthroplasty (THA) carried out by direct lateral approach (DLA)
Arm Title
THA Posterior
Arm Type
Experimental
Arm Description
Total hip arthroplasty (THA) carried out by posterior approach (DLA)
Arm Title
THA Anterior
Arm Type
Experimental
Arm Description
Total hip arthroplasty (THA) carried out by anterior approach (DLA)
Intervention Type
Procedure
Intervention Name(s)
Total hip arthroplasty direct lateral approach
Other Intervention Name(s)
Total hip replacement, THA
Intervention Type
Procedure
Intervention Name(s)
Total hip arthroplasty posterior approach
Other Intervention Name(s)
Total hip replacement, THA
Intervention Type
Procedure
Intervention Name(s)
Total hip arthroplasty, anterior approach
Other Intervention Name(s)
Total hip replacement, THA
Primary Outcome Measure Information:
Title
Muscle strength
Description
Measured by 1 repetition maximum (1 RM)
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
Hip joint functionality and mobility
Description
Measured by patient completed questionnaires and clinician reported scores
Time Frame
3 months postoperatively
Title
activity level
Description
Measured by an activity monitor
Time Frame
6 subsequent days postoperatively

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Jacob Stovner, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26141371
Citation
Winther SB, Husby VS, Foss OA, Wik TS, Svenningsen S, Engdal M, Haugan K, Husby OS. Muscular strength after total hip arthroplasty. A prospective comparison of 3 surgical approaches. Acta Orthop. 2016 Feb;87(1):22-8. doi: 10.3109/17453674.2015.1068032. Epub 2015 Aug 27.
Results Reference
result
PubMed Identifier
30421633
Citation
Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. Muscular strength and function after total hip arthroplasty performed with three different surgical approaches: one-year follow-up study. Hip Int. 2019 Jul;29(4):405-411. doi: 10.1177/1120700018810673. Epub 2018 Nov 13.
Results Reference
result

Learn more about this trial

Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results

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