| CTRI Number |
CTRI/2021/02/031279 [Registered on: 15/02/2021] Trial Registered Prospectively |
| Last Modified On: |
11/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of Functional results obtained after Surgical treatment for Wrist Fracture treated by Two different types of Plates |
|
Scientific Title of Study
|
A Comparative Study Of Functional Outcome Of Intra Articular Fracture Distal End Radius Treated With Variable Angle Locking Compression Plate Versus Fixed Angle Locking Compression Plate |
| Trial Acronym |
VA -LCP v/s FA-LCP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDeepak Kumar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS , RAIPUR |
| Address |
Department of Orthopaedics, Ground Floor,Room no 3, D Block, AIIMS Raipur, Tatibandh Road, Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
9465503789 |
| Fax |
|
| Email |
deepak.krgg@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Harshal Sakale |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, RAIPUR |
| Address |
Department of Orthopaedics, AIIMS, RAIPUR, CG
Raipur CHHATTISGARH 492099 India |
| Phone |
8518881731 |
| Fax |
|
| Email |
harshal2082@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepak Kumar |
| Designation |
Junior Resident |
| Affiliation |
MBBS, PG JUNIOR RESIDENT (MS ORTHO) |
| Address |
Department of ORTHOPAEDICS,Room no. 3, Ground Floor, D block, AIIMS Raipur, Tatibandh Road, Raipur
Raipur CHHATTISGARH 492099 India |
| Phone |
9465503789 |
| Fax |
|
| Email |
deepak.krgg@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aiims Raipur |
| Address |
Tatibandh Road, Raipur |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrDEEPAK KUMAR |
AIIMS RAIPUR |
Room no 3, DEPARTMENT OF ORTHOPAEDICS,D-BLOCK, GROUND FLOOR,AIIMS RAIPUR,TATIBANDH ROAD Raipur CHHATTISGARH |
9465503789
deepak.krgg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Open Reduction and Internal Fixation with Volar Locking Compression Plate |
All the patients with Intra articular fracture distal end radius (AO Classification AO 23.B1 , AO 23.B2 , AO 23.B3, AO 23.C1,AO 23.C2, AO23. C3 ) , fulfilling the inclusion criteria of the study will be the subjects of the study.They will be evaluated both clinically and radiologically for suitability of the surgery and evaluation of the fracture. All the patients willing to participate in the study , after they give consent , will be assigned either of the 2 groups randomly through Random Number Table method. All the patients will be treated with Modified Henry’s Volar approach.All the operated Patients will be followed for a period of 6 months, with one evaluation at 15 days post–surgery for suture removal and to check wound site and monthly for first 3 months and then at 6 months post-surgery to evaluate Range of motion at wrist by Mayo wrist score and Radiological outcome with Sarmiento modification of Lindstrom’s criteria.Any complication during procedure will be documented for each patient of both groups and treated according to the standard protocol.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Radiological findings confirming intra articular fracture of Distal End Radius according to AO classification ( Type 23.B1 to 23.C3)
2.Patient who are willing for surgery
3.Age group more than 18 years
|
|
| ExclusionCriteria |
| Details |
1.Patients with pathological fractures
2.Open fractures Gustilo and Anderson type II or type III
3.Fracture with neuro- vascular injury
4.Contralateral injury to wrist and carpals
5.Ipsilateral fracture of shoulder and elbow
6.Pregnant woman
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional and Radiological outcome using fixed and variable angle locking compression plate |
Patients will be followed for a period of 6 months, with one evaluation at 15 days post–surgery for suture removal and to check wound site and monthly for first 3 months and then at 6 months post-surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complications and other problems related to study |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/02/2021 |
| Date of Study Completion (India) |
20/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/12/2021 |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Distal radius fractures are the most common fractures of upper limb presenting in the emergency, compromising of more than 16% of all the fractures. Distal radial fractures have a bimodal type of age distribution with High-energy trauma contributing in younger and low energy trauma in Elderly population. Females are more liable to distal radius fractures when compared with males mainly because of more severe osteoporosis and a higher liability of elderly women to fall as compared to the age matched men.Consequently, a fracture of the distal radius is typically the result of a fall on an outstretched hand in a post menopausal woman, where a functionally active person suffers a trauma on an osteoporotic bone. About 60 years ago, most distal radial fractures were treated conservatively with satisfactory results. Recently, it has been clinically proved that intra-articular step-off and radial shortening corrected by surgery have improved patient outcome.In general, anatomic reduction and stable fixation should be pursued in younger and high-demand elderly patients to initiate early mobilization. Undisplaced or reducible but stable extra and intra-articular fractures can also be treated with casting. Extra articular fractures that are irreducible, intra-articular fractures and fractures for demanding patients who require early mobilization, are commonly treated with plating (more often with Volar plating), intra medullary fixation, external fixation or pinning. Dorsal plating is rarely used due to complications like extensor tendon rupture, tendinosis and volar collapse.Close reduction and cast immobilization has been the principal mode of management of distal radius fractures but it often lead to fracture malunion and subluxation/ dislocation of distal radio-ulnar joint, hence resulting in poor functional, radiographic and cosmetic result.The residual deformity of wrist adversely affected wrist motion and hand function, there by interfering with the mechanical advantage of the extrinsic hand musculature.It also causes pain, limitation of forearm motion, and decreased grip strength as a result of arthrosis of the radiocarpal and distal radioulnar joints. Open reduction and volar plating was designed to ensure more consistent correction of the displacement, maintenance of reduction and to initiate early range of movement exercises. The purpose of this study is to compare functional and radiological outcomes of variable angle locking compression to fixation strategies with fixed angle volar locking compression plates. |