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

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506024
• Other study ID #: 2011/450
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Total hip arthroplasty direct lateral approach

• Total hip arthroplasty posterior approach

• Total hip arthroplasty, anterior approach

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. 2018 Nov 13:1120700018810673. doi: 10.1177/1120 — View 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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength	Measured by 1 repetition maximum (1 RM)	3 months postoperatively
Secondary	Hip joint functionality and mobility	Measured by patient completed questionnaires and clinician reported scores	3 months postoperatively
Secondary	activity level	Measured by an activity monitor	6 subsequent days postoperatively