- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03673514
Anterior vs Posterior Approach in THA
Direct Anterior Versus Posterior Approach for Total Hip Arthroplasty: a Multicentric Prospective Randomized Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this multicentric, prospective, randomized clinical trial, 55 total hip arthroplasties were performed on 50 patients between February 2011 and July 2013. Patients meeting the inclusion criteria underwent surgical treatment using the DAA or PA, according to a randomization process. Radiological analysis assessed implant position, limb lengthening, and potential implant related complications. X-rays were performed at subsequent follow-up visits and consisted of an antero-posterior (AP) pelvic X-ray and a lateral projection of the hip. Two independent observers, not involved with patients or surgeries, reviewed all postoperative radiographs independently.Two fellowship-trained surgeons in two separate hospitals performed all procedures. Both surgeons had previously performed over 100 cases with each approach, before initiating this study.
Patients underwent either the posterior or direct anterior approach.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary total hip replacement due to osteoarthrosis or osteonecrosis
- patients older than 50 years.
Exclusion Criteria:
- inflammatory arthritis,
- any previous ipsilateral hip surgery
- suffering from proximal femoral deformity
- BMI over 40
- active infection
- severe contralateral hip disease, muscle contractures or neuromuscular pathology
- requiring structural bone grafts.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: THA Posterior Approach
The posterior approach to the hip has been described by many authors and yields good results.
Implants used were Quadra®-H stem and Versacup® hip system, Medacta, Switzerland, with metal on polyethylene bearing.
All implants were non-cemented.
|
Two fellowship-trained surgeons in two separate hospitals performed all procedures.
Both surgeons had previously performed over 100 cases with each approach, before initiating this study
|
|
ACTIVE_COMPARATOR: THA Direct anterior approach
The modified Hueter approach, based on the Smith-Peterson approach, was performed for the direct anterior minimally invasive surgery.
This approach could have some advantages as it is a muscle sparing approach, hence yielding a faster recovery.
A traction table was used for DAA as surgeons were trained to use this method.
No intra-operative fluoroscopy was used for implant confirmation.Implants used were Quadra®-H stem and Versacup® hip system, Medacta, Switzerland, with metal on polyethylene bearing.
All implants were non-cemented.
|
Two fellowship-trained surgeons in two separate hospitals performed all procedures.
Both surgeons had previously performed over 100 cases with each approach, before initiating this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital stay
Time Frame: Between 0 days and 1 month, average of 4 days
|
Length in days of hospital stay
|
Between 0 days and 1 month, average of 4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional recovery
Time Frame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
|
The Harris Hip Score (HHS) was used to measure pain and function.Grading for the Harris Hip Score is interpreted on a scale of 0 to 100 as follows: results <70 are Poor; 70 - 79 are Fair; 80-89 are Good; 90 -100 are Excellent
|
2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
|
|
pain assessment: VAS
Time Frame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
|
Visual Analog Scale (VAS) was used.
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases.
The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme.
The pain VAS is a single-item scale, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) .
It is one total score, without subscale.
As the lowest score of zero means no pain, it is the best possible outcome.
As the highest score of 100 means the worst imaginable pain, it is the worst possible outcome.
|
2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
|
|
implant position
Time Frame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
|
Radiological assessment
|
2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
|
|
number of patients with per/post surgical complications.
Time Frame: 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
|
Possible complications are: peroperative fracture, hip dislocation, infection, neurologic complication, vascular complication or hematoma.
|
2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively
|
|
surgical time
Time Frame: Up to 240 minutes
|
Surgical time in minutes
|
Up to 240 minutes
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CÉR : 2009-09-67;2010-415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Total Hip Arthroplasty
-
Northern Orthopaedic Division, DenmarkCompletedTotal Knee Arthroplasty | Total Hip ArthroplastyDenmark
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
Ortho Development CorporationOregon Health and Science UniversityEnrolling by invitationTotal Hip Replacement | Total Hip ArthroplastyUnited States
-
National Taiwan University HospitalUnknownTotal Hip Replacement | Total Hip ArthroplastyTaiwan
-
The Affiliated Hospital Of Southwest Medical UniversityCompletedTotal Knee Arthroplasty | Total Hip Arthroplasty | ERASChina
-
Bispebjerg HospitalNot yet recruitingTotal Hip Arthroplasty (THA) | Revision Hip Arthroplasty
-
James A. KeeneyCompletedPrimary Total Hip Arthroplasty | Primary Total Knee ArthroplastyUnited States
-
Musgrave Park HospitalBelfast Health and Social Care Trust; Queen's University, Belfast; Belfast Arthroplasty...CompletedTotal Hip Replacement | Total Hip Arthroplasty | THA | THRUnited Kingdom
-
Rush University Medical CenterRecruitingAnterior Cruciate Ligament Reconstruction | Total Knee Arthroplasty | Hip Arthroscopy | Total Hip Arthroplasty (THA)United States
Clinical Trials on Total hip arthroplasty
-
Masarykova Nemocnice v Usti nad Labem, Krajska...CompletedArthropathy of HipCzechia
-
Smith & Nephew, Inc.Active, not recruitingAdvanced Degeneration of the Hip Joint | Revision of the Hip JointUnited States, Australia, Canada, Hong Kong
-
Istituto Clinico HumanitasCompleted
-
DePuy OrthopaedicsTerminatedOsteoarthritis | Degenerative Arthritis | Revision ArthroplastyCanada
-
Rothman Institute OrthopaedicsCompleted
-
Suzhou MicroPort OrthoRecon Co. LTDCompleted
-
Norwegian University of Science and TechnologyOrtoMedic A/S, Oslo; Scandinavian Customized Prosthesis (SCP)CompletedOsteoarthritis, Hip
-
Western University, CanadaRecruiting
-
Zimmer BiometTerminatedJoint Diseases | Osteoarthritis, Hip | Avascular Necrosis of Hip | Congenital Dysplasia of the Hip | Degenerative Joint Disease of Hip | Rheumatoid Arthritis of Hip | Post-Traumatic Osteoarthritis of HipCanada