Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000229774
Ethics application status
Approved
Date submitted
22/10/2021
Date registered
9/02/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
9/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized controlled trial to compare functional outcomes between LOcking compression Plates and Retrograde Intramedullary Nails in distal femur fractures
Scientific title
Randomized controlled trial to compare functional outcomes between LOcking compression Plates and Retrograde Intramedullary Nails in distal femur fractures
Secondary ID [1] 305640 0
None
Universal Trial Number (UTN)
Trial acronym
LOPRIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Simple extra-articular Distal femur fracture (AO classification type 33A2/3) 324064 0
Condition category
Condition code
Injuries and Accidents 321577 321577 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment under investigation is retrograde intramedullary nailing. RIMN requires less extensive dissection and in a biomechanical study comparing RIMN with LCP and dynamic condylar screw, RIMN was found to have greatest stability for type 33A fractures. This method is routinely used for the stabilization of femoral fractures, including distal extraarticular ones.
A 3- to 4-cm incision is done through either a tendon split or a parapatellar arthrotomy. The nail is inserted in the intercondylar notch just anterior to the femoral attachment of the posterior cruciate ligament. Then a guide pin is inserted in line with the femoral shaft to ensure restoration of coronal plane alignment on both radiographic views. Next the entry reamer is used to open the metaphyseal segment. Cannulated soft tissue sleeves are used to prevent injury to the patellar tendon and articular surface of the patella. Once the fracture is reduced, the guide pin is inserted into the medullary canal, as far as approximately 12-14 cm proximal to the fracture zone. Reaming is done. Then drive the nail over the guide pin after confirmation of size and diameter of the nail. For retrograde femoral nailing to achieve adequate fracture stabilization, the fracture should be at least 6 cm from the joint line to achieve distal locking with screws. Distally, fix both screw holes, while proximally use one screw hole for fixation. Before the wound closure, perform thorough irrigation of the knee wound in order to minimize the risk of infection and to remove any debris from the joint. End the procedure with the closure of the tendon (as necessary), the deep tissues and the skin.

Orthopedic surgeon will perform the intervention and the process will take around 45 min to 1 hour.

Study schedule and randomization process will be diligently followed according to the study protocol.

Every eligible patient will be randomly allocated to either LCP or RIMN. The randomization list will be prepared using software by an independent researcher using random block sizes of 2, 4 and 6. This randomization list will not be available to those who enrol participants (study team members) or assign interventions (treating physician) to maintain concealment. Once the patient is in the operating theatre and is given anaesthesia for surgery, a telephone call will be made to the independent researcher to ask for the treatment allocation.
Neither the patient nor the surgeon can be blinded due to the difference in implants and wound patterns. Assessor(s)=physiotherapists will be blinded by covering the knees of the patient during assessment of functional score.
Intervention code [1] 322033 0
Treatment: Surgery
Comparator / control treatment
The comparator is locking compression plate. The Locking compression plate (LCP) can be used in either an open, or a minimally invasive manner. The open approach to the distal femur uses a lateral parapatellar arthrotomy, where the fracture site is visualized and fixed with plate. Minimally invasive plating of extra-articular distal femur fractures is performed with an incision through skin and the iliotibial band over the lateral condyle, followed by plate insertion through a submuscular tunnel along the lateral femur. Fracture site is not opened in minimally invasive approach. Correct plate application remains critical in minimally invasive technique with judicious use of fluoroscopy with perfect anteroposterior and lateral projections, minimizing the likelihood of both fracture malreduction and plate malpositioning.

The procedure will be performed by the orthopedic surgeon. It will take around 1 hour to complete the procedure.

If there is comminution, surgeon may prefer using minimally invasive procedure rather than opening the site of comminution.

Study schedule and randomization process will be diligently followed according to the study protocol.

Every eligible patient will be randomly allocated to either LCP or RIMN. The randomization list will be prepared using software by an independent researcher using random block sizes of 2, 4 and 6. This randomization list will not be available to those who enrol participants (study team members) or assign interventions (treating physician) to maintain concealment. Once the patient is in the operating theatre and is given anaesthesia for surgery, a telephone call will be made to the independent researcher to ask for the treatment allocation.
Neither the patient nor the surgeon can be blinded due to the difference in implants and wound patterns. Assessor(s)=physiotherapists will be blinded by covering the knees of the patient during assessment of functional score.
Control group
Active

Outcomes
Primary outcome [1] 329346 0
Wilde's modification of Neer knee score.
It is essentially a clinician-based score which assesses 5 domains in a scale from 1-4. The total score ranges from 5-20 points with higher scores, indicating better functional outcomes.
Timepoint [1] 329346 0
STUDY SCHEDULE

Screening/ preoperative day
Intraoperative (Day 0)
Postoperative (Day 1)
Discharge
2 weeks +/- 7 days
6 weeks +/- 7 days
12 weeks +/- 7 days
18 weeks +/- 7 days
6 months +/- 14 days---Primary endpoint
Secondary outcome [1] 402207 0

Treatment- or fracture- related complications such as infection, delayed union, implant failure, re-operations, loss of alignment >10°

assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Timepoint [1] 402207 0
1 year post surgery
Secondary outcome [2] 404607 0
Fluoroscopy time
Timepoint [2] 404607 0
Intra-operative use of fluoroscopy. This will be taken from patient medical records.
Secondary outcome [3] 404608 0
Fracture union assessment by RUST score (Radiographic union score for tibia),
Timepoint [3] 404608 0
12 months post-operative
Secondary outcome [4] 404609 0
PROMIS-10 global health scores
Timepoint [4] 404609 0
12 months post-operative

Eligibility
Key inclusion criteria
• Patients equal to or more than 18 years
• ASA grade 1-3
• Diagnosis of closed extra-articular distal femur fracture type 33A2/3
• Fracture requiring operative treatment amenable to either Retrograde Intramedullary nail (RIMN) or Locking compression plate (LCP)
• Surgical treatment within 7 days after injury
• Informed consent obtained, i.e.:
o Ability to understand the content of the patient information/ informed consent form (ICF)
o Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
o Signed and dated ethics committee (EC)/ institutional review board (IRB) approved written informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pathological fractures
• Peri-prosthetic fractures
• Poor skin condition overlying skin incision
• Pre-existing knee arthritis
• Unfit for anesthesia
• Fractures with vascular injury requiring repair
• Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
• Soft tissue injuries compromising treatment method with either nail or plate
• Diagnosed metabolic bone disease
• Mentally incompetent patients (a person who cannot make or carry out important decisions regarding his or her affairs).
• Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
1/07/2022
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
96
Accrual to date
96
Final
Recruitment outside Australia
Country [1] 24246 0
Pakistan
State/province [1] 24246 0

Funding & Sponsors
Funding source category [1] 309999 0
Hospital
Name [1] 309999 0
Lady Reading Hospital
Country [1] 309999 0
Pakistan
Primary sponsor type
Individual
Name
Syed Imran Bukhari
Address
Orthopedics department, Lady Reading Hospital, Soekarno chowk, PO Box; 25000, Peshawar, Khyber Pakhtunkhwa, Pakistan
Country
Pakistan
Secondary sponsor category [1] 311049 0
None
Name [1] 311049 0
-
Address [1] 311049 0
-
Country [1] 311049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309709 0
Instituitional Review Board, Lady Reading Hospital
Ethics committee address [1] 309709 0
Ethics committee country [1] 309709 0
Pakistan
Date submitted for ethics approval [1] 309709 0
01/10/2021
Approval date [1] 309709 0
24/06/2022
Ethics approval number [1] 309709 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115118 0
A/Prof Syed Imran Bukhari
Address 115118 0
Department of Orthopedics, Lady Reading Hospital, Soekarno chowk, Peshawar, Khyber Pakhtunkhwa, Pakistan.
PO Box. 25000
Country 115118 0
Pakistan
Phone 115118 0
+923339630619
Fax 115118 0
Email 115118 0
[email protected]
Contact person for public queries
Name 115119 0
Syed Imran Bukhari
Address 115119 0
Department of Orthopedics, Lady Reading Hospital, Soe Karno chowk, Peshawar, Khyber Pakhtunkhwa, Pakistan.
PO Box.. 25000
Country 115119 0
Pakistan
Phone 115119 0
+923339630619
Fax 115119 0
Email 115119 0
[email protected]
Contact person for scientific queries
Name 115120 0
Syed Imran Bukhari
Address 115120 0
Department of Orthopedics, Lady Reading Hospital, Soe Karno chowk, Peshawar, Khyber Pakhtunkhwa, Pakistan.
PO Box. 25000
Country 115120 0
Pakistan
Phone 115120 0
+923339630619
Fax 115120 0
Email 115120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.