| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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.
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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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 |
|
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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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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. |