Femur FractureNCT06307587
Vastus Intermedius Dry Needling for Knee Stiffness Resulted From Surgically Managed Femoral Fractures With Open Reduction & Internal Fixation.
A study testing dry needling in people with Femur Fracture, run by Al-Razi Hospital.
Trial summary
Orthopedic traumatic injuries are considered a major health epidemic, challenged by high morbidity, mortality, and socioeconomic burden. The management of traumatic orthopedic injuries is challenging and complex, with high resources utilization. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Femur Fracture
- What is being tested?
- dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 12 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 55-year-old participants.
- Distal one third femur fractures classified as type 33 with AO/OTA classification.
- Three months post ORIF surgery to the distal femoral fracture,
- Experience postoperative limitation in knee flexion range of motion of less than 90 degrees.
Who cannot join
- Neuropathic pain in the lower limb.
- Lumbosacral radiculopathy,
- Saphenous nerve entrapment,
- Meralgia paresthetica,
- Rheumatoid or systemic conditions,
- Other surgeries,
Show all 14Show fewer
- Post-surgery complications (i.e., thrombosis or osteomyelitis) or use of heparin during DN.
- Knee surgery,
- Periprosthetic fractures,
- Scraw fixation only,
- Intermedullary nail fixation,
- non-union,
- Isolated medial or lateral condyle femoral fractures,
- Underwent manipulation under anesthesia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vastus Intermedius Dry Needling for Knee Stiffness Resulted From Surgically Managed Femoral Fractures With Open Reduction & Internal Fixation; Randomized Controlled Trial (ORIFDN Trial)
Orthopedic traumatic injuries are considered a major health epidemic, challenged by high morbidity, mortality, and socioeconomic burden. The management of traumatic orthopedic injuries is challenging and complex, with high resources utilization. Particularly, the prevalence of femoral fractures in Kuwait is 8.8%, being one of the most prevalent injuries. Open reduction and internal fixation (ORIF) is a common surgical procedure for the management of femoral fractures demonstrating successful outcome for allowing minimally invasive percutaneous plate osteosynthesis, early union of 93% to 100%, and low infection rate of only 0% to 2%. Yet, one of the major complications post ORIF is knee stiffness and reduced function, which brings many inconveniences to patients' daily lives, lead to disability, and could seriously threaten the functional activities of patients. The incidence of knee stiffness requiring surgical intervention is 14.5%. Particularly, the potential loss of knee flexion is 30 to 40 degrees, 13% of the patients failed to reach 90 degrees of knee flexion, and only 48% of patients reached >120 degrees of flexion. Ultimately, knee stiffness in flexion forms a major issue in distal femoral fractures. Various reasons could explain such complication including intrinsic adhesions, fibrosis and shortening of the vastus intermedius muscle.
There are various surgical procedures which could be used to manage knee stiffness. However, there is no consensus regarding the ideal approach and strategy with many postoperative complications including deep sepsis, quadricep tendon rupture, skin dehiscence and infection, delayed wound healing, patella fracture, lateral femoral condyle fracture and extension lag. In contrast, dry needling (DN) is a minimal invasive intervention for the management of musculoskeletal dysfunction, and it could be used to reduce the adhesion and fibrosis between the vastus intermedius and the femoral bone. However, there is limited research investigating the effect of DN on the vastus intermedius muscle after ORIF of the femoral fractures. The effectiveness of DN was explored for the management of various musculoskeletal conditions, and a systematic review addressing DN in the lower quarter concluded that DN is an effective procedure (Morihisa et a,., 2016). In ACL reconstruction, DN for the vastus medialis improved ROM at short-term and improved function at both short and long term. DN has been proposed as a useful addition to the rehabilitation of ACL reconstructed in reducing pain intensity, increasing knee flexion range, and modifying the mechanical properties of the quadriceps muscle during the late-stage of rehabilitation. DN has also altered the passive mechanical properties of the quadriceps muscle where decrement and resistance of the vastus medialis were significantly reduced. It is hypothesized that releasing the adhesions and fibrosis of the vastus intermedius could play an important role in managing knee stiffness post ORIF of the distal femur fractures. Therefore, the aim of this project is to identify the incidence rate and risk factors of knee stiffness resulted from surgically managed femoral fractures with open reduction and internal fixation in Kuwait, and to investigate the effect of DN on the vastus intermedius muscle in improving knee joint range of motion and function after ORIF of the distal femur using single blind randomized controlled trial (RCT).
- Conditions
- Femur Fracture
- Being tested
- dry needling
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingProcedure or surgery
The vastus intermedius will be approached with DN from the lateral aspect and the pincer approach will be followed. The Hong fast-in and fast out technique with multiple rapid needle insertions will be performed following previous recommendations (Chou, et al., 2014). The control group will receive the rehabilitation program alone. A headless 0.25 × 25-mm needle (Stainless steel, Agupunt A1038P, 158 Caspe, Barcelona, Spain) will be used. The penetration depth will be varied according to the patient. Hemostasis will be performed for 1 minutes. DN will be performed medial to the sartorius muscle limit to avoid saphenous nerve adverse effects during DN (Henry et al., 2016).
| Study group | Role | What they receive |
|---|---|---|
| DN group | Active comparator | Not described Receives: Procedure: dry needling |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee flexion range of motion
Knee flexion range of motion will be the primary outcome measure, which will be measured with standard goniometry in supine position considering the lateral femoral epicondyle as the center of the fulcrum. Knee extension will also be measured in supine position.
Measured: one month, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Razi Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Najla Alsiri, Al-Razi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307587
- Sponsor's protocol ID
- 2023/2355
- Status last verified
- Jul 2024
- First submitted
- 6 Mar 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vastus Intermedius Dry Needling for Knee Stiffness Resulted From Surgically Managed Femoral Fractures With Open Reduction & Internal Fixation; Randomized Controlled Trial (ORIFDN Trial)
- ClinicalTrials.gov ID
- NCT06307587
- Acronym / sponsor ID
- 2023/2355
- Conditions
- Femur Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Al-Razi HospitalOther government
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Orthopedic traumatic injuries are considered a major health epidemic, challenged by high morbidity, mortality, and socioeconomic burden. The management of traumatic orthopedic injuries is challenging and complex, with high resources utilization. Particularly, the prevalence of femoral fractures in Kuwait is 8.8%, being one of the most prevalent injuries. Open reduction and internal fixation (ORIF) is a common surgical procedure for the management of femoral fractures demonstrating successful outcome for allowing minimally invasive percutaneous plate osteosynthesis, early union of 93% to 100%, and low infection rate of only 0% to 2%. Yet, one of the major complications post ORIF is knee stiffness and reduced function, which brings many inconveniences to patients' daily lives, lead to disability, and could seriously threaten the functional activities of patients. The incidence of knee stiffness requiring surgical intervention is 14.5%. Particularly, the potential loss of knee flexion is 30 to 40 degrees, 13% of the patients failed to reach 90 degrees of knee flexion, and only 48% of patients reached >120 degrees of flexion. Ultimately, knee stiffness in flexion forms a major issue in distal femoral fractures. Various reasons could explain such complication including intrinsic adhesions, fibrosis and shortening of the vastus intermedius muscle.
There are various surgical procedures which could be used to manage knee stiffness. However, there is no consensus regarding the ideal approach and strategy with many postoperative complications including deep sepsis, quadricep tendon rupture, skin dehiscence and infection, delayed wound healing, patella fracture, lateral femoral condyle fracture and extension lag. In contrast, dry needling (DN) is a minimal invasive intervention for the management of musculoskeletal dysfunction, and it could be used to reduce the adhesion and fibrosis between the vastus intermedius and the femoral bone. However, there is limited research investigating the effect of DN on the vastus intermedius muscle after ORIF of the femoral fractures. The effectiveness of DN was explored for the management of various musculoskeletal conditions, and a systematic review addressing DN in the lower quarter concluded that DN is an effective procedure (Morihisa et a,., 2016). In ACL reconstruction, DN for the vastus medialis improved ROM at short-term and improved function at both short and long term. DN has been proposed as a useful addition to the rehabilitation of ACL reconstructed in reducing pain intensity, increasing knee flexion range, and modifying the mechanical properties of the quadriceps muscle during the late-stage of rehabilitation. DN has also altered the passive mechanical properties of the quadriceps muscle where decrement and resistance of the vastus medialis were significantly reduced. It is hypothesized that releasing the adhesions and fibrosis of the vastus intermedius could play an important role in managing knee stiffness post ORIF of the distal femur fractures. Therefore, the aim of this project is to identify the incidence rate and risk factors of knee stiffness resulted from surgically managed femoral fractures with open reduction and internal fixation in Kuwait, and to investigate the effect of DN on the vastus intermedius muscle in improving knee joint range of motion and function after ORIF of the distal femur using single blind randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DN group | Active comparator | Procedure: dry needling |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 55-year-old participants.
- Distal one third femur fractures classified as type 33 with AO/OTA classification.
- Three months post ORIF surgery to the distal femoral fracture,
- Experience postoperative limitation in knee flexion range of motion of less than 90 degrees.
Key exclusion criteria (14 listed)
- Neuropathic pain in the lower limb.
- Lumbosacral radiculopathy,
- Saphenous nerve entrapment,
- Meralgia paresthetica,
- Rheumatoid or systemic conditions,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingThe vastus intermedius will be approached with DN from the lateral aspect and the pincer approach will be followed. The Hong fast-in and fast out technique with multiple rapid needle insertions will be performed following previous recommendations (Chou, et al., 2014). The control group will receive the rehabilitation program alone. A headless 0.25 × 25-mm needle (Stainless steel, Agupunt A1038P, 158 Caspe, Barcelona, Spain) will be used. The penetration depth will be varied according to the patient. Hemostasis will be performed for 1 minutes. DN will be performed medial to the sartorius muscle limit to avoid saphenous nerve adverse effects during DN (Henry et al., 2016). | Procedure or surgery | DN group |
Primary outcome
knee flexion range of motion
Time frame: one month, 6 months, 12 months
Knee flexion range of motion will be the primary outcome measure, which will be measured with standard goniometry in supine position considering the lateral femoral epicondyle as the center of the fulcrum. Knee extension will also be measured in supine position.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling in people with Femur Fracture, run by Al-Razi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Najla Alsiri, PhD (00965-66820032, dr.alsiri@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee flexion range of motion (time frame: one month, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.