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OpenTrials
Completed

NCT Number: NCT01959360

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

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.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Direct lateral

Procedure

Total hip replacement; direct lateral approach

minimal invasive

Procedure

Total hip replacement; minimal invasive approach

modified minimal invasive

Procedure

Total hip replacement; modified minimal invasive approach

Primary outcomes

  1. Implant stability

    Time frame: 2 years

Secondary outcomes

  1. Implant stability

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2018
First posted
Oct 10, 2013
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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