Overview

This trial is active, not recruiting.

Condition hip osteoarthritis
Treatments direct lateral, minimal invasive, modified minimal invasive
Sponsor Norwegian University of Science and Technology
Collaborator St. Olavs Hospital
Start date August 2011
End date June 2017
Trial size 60 participants
Trial identifier NCT01959360, 100889

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
direct lateral
Total hip replacement; direct lateral approach
(Experimental)
minimal invasive
Total hip replacement; minimal invasive approach
(Experimental)
modified minimal invasive
Total hip replacement; modified minimal invasive approach

Primary Outcomes

Measure
Implant stability
time frame: 2 years

Eligibility Criteria

Male or female participants from 25 years up to 70 years old.

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.

Additional Information

Official title Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.