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Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Direct lateral
minimal invasive
modified minimal invasive
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, Total Hip Replacement, Hip, Surgical Procedures, Operative, Surgical Procedures, Minimally Invasive

Eligibility Criteria

25 Years - 70 Years (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

direct lateral

minimal invasive

modified minimal invasive

Arm Description

Outcomes

Primary Outcome Measures

Implant stability

Secondary Outcome Measures

Implant stability

Full Information

First Posted
October 8, 2013
Last Updated
May 13, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01959360
Brief Title
Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications
Official Title
Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2018 (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

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Arthroplasty, Total Hip 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
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
direct lateral
Arm Type
Active Comparator
Arm Title
minimal invasive
Arm Type
Experimental
Arm Title
modified minimal invasive
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Direct lateral
Intervention Description
Total hip replacement; direct lateral approach
Intervention Type
Procedure
Intervention Name(s)
minimal invasive
Intervention Description
Total hip replacement; minimal invasive approach
Intervention Type
Procedure
Intervention Name(s)
modified minimal invasive
Intervention Description
Total hip replacement; modified minimal invasive approach
Primary Outcome Measure Information:
Title
Implant stability
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Implant stability
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
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

Learn more about this trial

Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications

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