FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047482 [Registered on: 21/11/2022] Trial Registered Prospectively
Last Modified On: 19/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   patient satisfaction and activities patient can perform following Total Hip Replacement via two different surgical approaches 1)direct anterior and 2) posterior 
Scientific Title of Study   Clinicoradiological outcomes and patient satisfaction following total hip arthroplasty via direct anterior approach vs posterior approach (a prospective randomized controlled trial) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishna Kiran Eachempati 
Designation  HOD and DIrector of Orthopedics 
Affiliation  Medicover Hospital 
Address  Room no. 1, lower ground floor, OPD building, Medicover Hospital, Hitech city, Madhapur

Hyderabad
TELANGANA
500081
India 
Phone  9989049988  
Fax    
Email  kke1975@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishna Kiran Eachempati 
Designation  HOD and DIrector of Orthopedics 
Affiliation  Medicover Hospital 
Address  Room no. 1, lower ground floor, OPD building, Medicover Hospital, Hitech city, Madhapur


TELANGANA
500081
India 
Phone  9989049988  
Fax    
Email  kke1975@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishna Kiran Eachempati 
Designation  HOD and DIrector of Orthopedics 
Affiliation  Medicover Hospital 
Address  Room no. 1, lower ground floor, OPD building, Medicover Hospital, Hitech city, Madhapur


TELANGANA
500081
India 
Phone  9989049988  
Fax    
Email  kke1975@gmail.com  
 
Source of Monetary or Material Support  
Medicover Hospital, Hitech city, near IBIS hotel, Madhapur, Hyderabad - 500081 
 
Primary Sponsor  
Name  NA 
Address  N/A 
Type of Sponsor  Other [N/A] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshil Shah  Medicover Hospital  Room no.1, Lower ground floor, Orthopedics department, OPD building, Hitech city, Madhapur
Hyderabad
TELANGANA 
8780096259

harshilnshah29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M163||Unilateral osteoarthritis resulting from hip dysplasia, (2) ICD-10 Condition: M165||Unilateral post-traumatic osteoarthritis of hip, (3) ICD-10 Condition: M167||Other unilateral secondary osteoarthritis of hip, (4) ICD-10 Condition: M870||Idiopathic aseptic necrosis of bone, (5) ICD-10 Condition: M871||Osteonecrosis due to drugs, (6) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, (7) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (8) ICD-10 Condition: M15-M19||Osteoarthritis, (9) ICD-10 Condition: M16||Osteoarthritis of hip,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Direct Anterior Approach  Total Hip Arthroplasty via Direct Anterior Approach to chech functional outcomes, clinical outcomes and patient satisfaction for 1 year 
Comparator Agent  Posterior Approach  Total Hip Arthroplasty via Posterior Approach to check and compare with intervention agent for function and clinical outcomes, patient satisfaction for 1 year 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients with osteoarthritis, osteonecrosis, or dysplasia of hip with end stage arthritis warranting primary total hip arthroplasty in unilateral hip
American Society of Anaesthesiologists (ASA) grade 1 or 2
 
 
ExclusionCriteria 
Details  Patients who had previously undergone any kind of surgery in affected hip
Patients undergoing revision Total Hip arthroplasty
Patients with a proximal femoral deformity
Patient having an active infection
Patient having severe contralateral hip disease
Patient having neuromuscular pathology
Patient with severe bone defect or requiring structural bone grafts.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1 radiological outcome: Compare radiological outcome by taking x-ray
2 Clinical outcome: Compare overall clinical outcomes between two group using Harris Hip Score and WOMAC score
3 Functional outcome: Compare the satisfactory outcome between the two groups using SF-36 score modified Forgotten Joint Score
 
At 6 weeks, 6 months, 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1 To compare peri-operative parameters like Drop of Hemoglobin, intra/immediate post-operative complication, duration of surgery
2 To compare the length of hospital stay after undergoing Total Hip Arthroplasty via two different approaches
3 To compare the 90-days complication rates following Total Hip Arthroplasty via two different approaches
4 To compare the patient satisfaction following Total Hip Arthroplasty via two different approaches
 
intra-operative, immediate post-operative 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/11/2022 
Date of Study Completion (India) 21/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Other (Terminated) 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Total hip arthroplasty (THA) is one of the commonly performed surgeries in orthopedics. THA is performed for various indications like end-stage degenerative hip osteoarthritis (OA), hip osteonecrosis (ON), congenital hip disorders, post-traumatic arthritis of hip, inflammatory arthropathies of hip. It is done for pain relief, functional restoration and overall improvement in quality of life. Hip osteoarthritis (OA) is the most prevalent and disabling conditions affecting the elderly. There is an estimated 25% lifetime risk of symptomatic hip OA in people who live to age 85 years.

          There are 3 classic approaches for THA, each with advantages and disadvantages: the Direct Anterior Approach, the Posterior Approach and the Lateral Approach.

           The direct anterior approach to the hip was originally described by Carl Heuter in 1881. Smith-Peterson had frequently used this approach and modified over the years and popularized this approach in 1920s-1930s. The anterior-based incision utilizes the interval between the tensor fascia lata and the sartorius muscles. The main advantage of the approach to be the muscle-sparing nature, earlier restoration of gait kinematics and low dislocation rates. The direct anterior approach can be performed with or without the use of a specialized table. Main challenges in anterior approach is limited exposure, difficulty in obese patient, and duration of surgery increases due to limited exposure, also it has steep learning curve.

             The posterior approach to the hip was popularized by Moore in the 1950s. The posterior approach is the most common surgical approach used globally for THAs. It provides adequate visualization of both the acetabulum and femur during both reconstructive procedures. The approach spares the abductor muscles during surgical exposure of the acetabulum and femur. Main drawback of posterior approach was dislocation due to cutting of short external rotators of hip. However, dislocation became less common with the PA because of enhanced capsular closure and larger heads.

              The direct lateral approach to the hip was described by Hardinge in 1982. This approach provides adequate exposure of both the proximal femur and acetabulum. It has the benefit of providing an extensive exposure to the femur as required. A very low dislocation rate has also been reported in clinical follow-up. However main drawback of this approach is abductor weakness as we split abductors of hip.

 
Close