Comparison of MIS Anterior Versus MIS Anterolateral Approach

Status Recruiting

Clinical Trial Summary

Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS (minimally invasive surgery) anterior approach with the MIS anterolateral approach to the hip.

Clinical Trial Description

The surgical approach to the hip is reportedly an important factor influencing implant stability and postsurgical muscle functioning. Reviewing the literature, controversial studies towards minimally invasive hip surgery can be found. Currently, none of the approaches can be considered superior, but the trend is towards minimally invasive techniques, as it is generally accepted that muscle trauma and damage of the periarticular structures should be minimized. However, a surgical approach that causes no damage to surrounding muscle is unrealistic. Whether the muscle is stretched, transacted or partially torn, injury will occur.

Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS anterior approach with the MIS anterolateral approach to the hip. The investigators questioned, which technique would be the less invasive? Pain and functional performance will be measured using the Harris Hip Score, the Western Ontario McMaster, and the UCLA (University of California) Activity Score. Subject quality-of-life will be determined by evaluation the Short-Form 36 Health Survey. Standard radiographs of the hip are required to be captured before surgery and at 3, 6 and 12 months postoperatively. MRI scans will be performed to evaluate tendon defects, fatty atrophy and changes in the muscle cross-sectional area. Next, the patients will be referred for hip sonography, performed by a radiologist who is experienced in imaging of the musculoskeletal system who will be unaware of the clinical examination results of the patients. Moreover gait analyses will be performed preoperatively, 3 and 12 months after surgery. Pre- and postoperative standard blood tests and specific serum trauma markers will be obtained. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02458144
Study type	Interventional
Source	Medical University of Vienna
Contact	Christoph Stihsen, Registrar
Phone	00431 40400
Email	christoph.stihsen@meduniwien.ac.at
Status	Recruiting
Phase	N/A
Start date	January 2013
Completion date	December 2016

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01312285` - Low Level Magnetic Fields for the Treatment of Osteoarthritis of the Hip	Phase 2
Completed	`NCT02102334` - Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty	N/A
Not yet recruiting	`NCT02279277` - Physical Therapy Prior to Total Knee Replacement	N/A
Completed	`NCT01501955` - The Metaphyseal Hip Prosthesis - Total Hip	N/A
Completed	`NCT06211465` - Cardiovascular And Metabolic Risk After Arthroplasty
Terminated	`NCT02299271` - Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty	Phase 4
Completed	`NCT01807104` - Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach	N/A
Terminated	`NCT02698865` - The MONOVISC Hip Osteoarthritis Study	Phase 3
Completed	`NCT03382262` - Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip	Phase 2
Completed	`NCT01795781` - Assays for and Reversal of New Anticoagulants	N/A
Recruiting	`NCT00449228` - Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement	Phase 3
Withdrawn	`NCT00758329` - Retrospective Data Review of ReCap Total Hip Resurfacing	N/A
Active, not recruiting	`NCT00951145` - Medium and Long Term Outcome of Total Hip Arthroplasty Using Accolade TMZF Femoral Stem	N/A
Completed	`NCT02230657` - A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.