| CTRI Number |
CTRI/2024/08/073143 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| 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
|
Use of cemented vs uncemented screws in proximal femur nailing for intertrochanteric fracture |
|
Scientific Title of Study
|
A Randomized Control Trial comparing functional and radiological outcomes in management of intertrochanteric fractures of femur using dual screws without cementation vs. dual screws with cementation. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishabh Verma |
| Designation |
Junior Resident |
| Affiliation |
aiims raipur |
| Address |
Junior resident
Department of orthopaedics
D block
Hospital building
Aiims raipur
Tatibandh-492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9639985332 |
| Fax |
|
| Email |
rishabhverma434@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr. Alok Chandra Agrawal |
| Designation |
Head of the Department |
| Affiliation |
aiims raipur |
| Address |
Dept of orthopaedics
D block
AIIMS Raipur
Tatibandh-492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9425151634 |
| Fax |
|
| Email |
dralokcagrawal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Rishabh Verma |
| Designation |
PG student |
| Affiliation |
aiims raipur |
| Address |
Department of orthopaedics
D block
Hospita building
AIIMS Raipur
Tatibandh-492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9639985332 |
| Fax |
|
| Email |
rishabhverma434@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Raipur
India-492099 |
|
|
Primary Sponsor
|
| Name |
Dr Rishabh Verma |
| Address |
Pg student
Department of orthopaedics
Aiims raipur
Tatibandh
Raipur-492099 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RISHABH VERMA |
AIll India Institute of Medical Sciences |
ORTHOPAEDICS DEPARTMENT
GROUND FLOOR, D BLOCK
Raipur
CHHATTISGARH |
9639985332
rishabhverma434@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 7||Osteopathic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cementation of screws
|
1. Thorough history and examination to be done for patients coming in AIIMS, Raipur for intertrochanteric femur fractures.
2. All the patients fulfilling the inclusion criteria of the study, after they give informed consent will be the subjects of the study.
3. Outcome variables described above will be recorded
4. The method of injecting bone cement:
• Cement used is low viscosity cement (Heraeus PalacosLV).
• Cement will be injected using a syringe.
5. Immediate postoperative radiographs will be reviewed to reduction quality and to determine intra-articular leakage of cement. The postoperative reduction quality of the patients will be determined as good, acceptable, or poor according to Baumgartner criteria.
6. During follow-up, radiographs will be reviewed for non-union and union at intervals of one, three and six months
|
| Comparator Agent |
Screws without cementation |
Thorough history and examination to be done for patients coming in AIIMS, Raipur for intertrochanteric femur fractures. 2. All the patients fulfilling the inclusion criteria of the study, after they give informed consent will be the subjects of the study. 3. Outcome variables described above will be recorded 4. Immediate postoperative radiographs will be reviewed to reduction quality.The postoperative reduction quality of the patients will be determined as good, acceptable, or poor according to Baumgartner criteria. 5. During follow-up, radiographs will be reviewed for non-union and union at intervals of one, three and six months |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Radiological findings
confirming intertrochanteric fractures
2.Patients more than 50 years
of age
|
|
| ExclusionCriteria |
| Details |
1.Patients with pathological fracture
2.Patients with other lower limb fractures
3.Presence of infection in affected limb
4.Those with open fractures
5. Patient unwilling for surgery
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The radiological and functional outcomes in patients with proximal femur nailing. |
Baseline, one month, three months and six months from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objectives of this study are
Complications of proximal femoral nailing such as
Non-union
Screw cutout
Infection
Osteonecrosis of the femoral head
Implant breakage
Sepsis
Joint stiffness
|
quality of post op xrays at baseline ,1,3 & 6 months from baseline |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Functional and Radiological Outcomes of Dual Screws with and without Cementation in Intertrochanteric Femur Fractures: A Randomized Controlled Trial Background: Intertrochanteric hip fractures are prevalent among the elderly and pose substantial healthcare burdens. Commonly resulting from falls in osteoporotic individuals, these fractures are associated with perioperative complexities due to comorbidities. Intramedullary implants, such as dual screws, are frequently utilized for managing unstable pertrochanteric fractures. However, mechanical failures, including catastrophic events like cut-out or cut-through, remain a concern despite optimal reduction and implant placement. Bone cement augmentation around screws offers potential to enhance primary stability and long-term implant anchorage. Justification: Given the clinical significance of reducing catastrophic failures and associated complications, investigating the efficacy of bone cement augmentation in mobile elderly patients with closed unstable trochanteric fractures is crucial. This study aims to evaluate the impact of bone cement use on radiological and functional outcomes, including postoperative radiographs, complications, and hip function scores. Study Design: This randomized controlled trial will compare outcomes between two cohorts: one receiving dual screws with bone cement augmentation and the other without augmentation. Radiological assessments, complications, and functional outcomes, measured through modified Harris Hip Score and Numerical Pain Rating Score, will be evaluated postoperatively. The concise title encapsulates the study’s focus on assessing the effects of dual screw fixation with and without cementation on functional and radiological outcomes in intertrochanteric femur fractures. |