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

NCT ID: NCT01959360

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2018-12-31

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.

Conditions

Hip Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

direct lateral

Group Type: ACTIVE_COMPARATOR

Direct lateral

Intervention Type: PROCEDURE

Total hip replacement; direct lateral approach

minimal invasive

Group Type: EXPERIMENTAL

minimal invasive

Intervention Type: PROCEDURE

Total hip replacement; minimal invasive approach

modified minimal invasive

Group Type: EXPERIMENTAL

modified minimal invasive

Intervention Type: PROCEDURE

Total hip replacement; modified minimal invasive approach

Interventions

Direct lateral

Total hip replacement; direct lateral approach

Intervention Type: PROCEDURE

minimal invasive

Total hip replacement; minimal invasive approach

Intervention Type: PROCEDURE

modified minimal invasive

Total hip replacement; modified minimal invasive approach

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Jacob Stovner, prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

St Olavs Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

100889

Identifier Type: -

Identifier Source: org_study_id