Metacarpal FractureGRIPNCT07616947
Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization
A study testing ORIF, IMSF and CRPP in people with Metacarpal Fracture and Phalanx Fracture, run by Spencer B Chambers at 1 site in Canada.
Trial summary
Broken bones in the hand are common injuries that can make it hard to move fingers, grip objects, and return to work. When these breaks happen in the long bones of the hand (called metacarpals and phalanges), surgery is often needed to hold the bones in the right place while they heal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metacarpal Fracture, Phalanx Fracture
- What is being tested?
- ORIF, IMSF and CRPP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 1 Oct 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The MC arm:
- surgical management within 10 days of injury
- extraarticular fractures, clinical scissoring
- sagittal angulation in accordance with accepted norms (Table 1)
- shortening >5mm, translation >50%.
- The phalangeal arm:
Show all 11Show fewer
- surgical management within 10 days of injury
- extraarticular fractures, clinical scissoring
- sagittal angulation >20°
- shortening >2mm
- translation >50%.
Who cannot join
- < 18 years old
- unable to read English, provide consent, or return to follow-up.
- Injuries with concomitant soft tissues loss, tendon injury, nerve injury, infection, or fractures with severe comminution
- history of prior surgical management of a fracture of the ipsilateral hand
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization in the Treatment of Phalangeal and Metacarpal Fractures: A Randomized Control Trial
Broken bones in the hand are common injuries that can make it hard to move fingers, grip objects, and return to work. When these breaks happen in the long bones of the hand (called metacarpals and phalanges), surgery is often needed to hold the bones in the right place while they heal.
There are a few different ways surgeons can fix these broken bones. Two common methods are:
Read more
CRPP (Closed Reduction and Percutaneous Pinning): The bones are moved back into place without opening the skin, and thin metal pins are used to hold them.
IMSF (Intramedullary Screw Fixation): A small screw is placed inside the bone to hold it in position.
Another approach sometimes used for larger bones in the hand is ORIF (Open Reduction and Internal Fixation), where the bone is exposed through a small incision and held with plates or screws.
This study will compare how well these methods work. Investigators want to find out if using an intramedullary screw (IMSF) helps patients heal faster and move their hands more easily compared to the other common methods (CRPP and ORIF). Investigators will look at how quickly patients regain movement, how soon they can return to work, how satisfied they are with their recovery, and whether there are any problems or complications from surgery.
To do this, investigators will run a randomized controlled trial-this means patients will be stratified based on fracture location (metacarpals or phalanges) and randomly assigned to a treatment arm. For patients with metacarpal fractures, investigators will compare IMSF vs CRPP vs ORIF using a dorsal plate. For patients with proximal or middle phalangeal fractures investigators will compare IMSF to CRPP. Investigators will measure their recovery using both clinical tests and patient surveys over time. The results of this research will help surgeons choose the best and safest way to treat hand fractures so patients can heal faster and get back to their daily lives sooner
Read the detailed description
Metacarpal and phalangeal fractures are common traumatic injuries of the hand.1 Many can be treated conservatively, but when there is malalignment or instability, operative reduction and stabilization is required.2,3 Closed reduction and percutaneous pinning (CRPP), or open reduction and internal fixation (ORIF) using plates, screws, or wires are common methods of treatment.4-6 Percutaneous fixation allows stabilization of fractures with minimal soft tissue disruption,7-11 and although technically challenging, if successful, secondary complications such as tendon adhesions and abnormal scarring are uncommon.9 Conversely, open methods require broader exposure resulting in swelling and increased risk of scarring9, but facilitates early active motion allowing earlier return to function.3,10 Intramedullary screw fixation (IMSF) is a technique that is gaining popularity12,13 as it maintains the minimally invasive benefits of CRPP while providing stability similar to ORIF.14 In correctly selected fractures, IM screws facilitate early recovery with minimal down time, allowing expedited treatment and less loss of productivity.3,12,13 Investigators believe IM screws have notable advantages compared to CRPP. Allowing earlier rehabilitation, less external immobilization, and earlier functional recovery has potential to improve quality of life and reduce productivity loss.
These procedures are used currently within St. Joseph's Health Care London but there is debate regarding there efficacy and specific surgical technique varies amongst practitioners. The comparison comes between the specific surgical intervention, as although some surgeons have rapidly adapted this technique, is efficacy compared to more classic techniques has not been explored using high level studies, leaving its specific utility less clear.
- Conditions
- Metacarpal Fracture, Phalanx Fracture
- Being tested
- ORIF, IMSF, CRPP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIFProcedure or surgery
Also called CRPP
Open Reduction and Internal Fixation
IMSFProcedure or surgery
Intramedullary Screw Fixation
CRPPProcedure or surgery
Closed Reduction and Percutaneous Pinning
| Study group | Role | What they receive |
|---|---|---|
| Open Reduction and Internal Fixation | Experimental | patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate Receives: Procedure: ORIF |
| Closed Reduction and Percutaneous Pinning | Experimental | we will compare proximal or middle phalangeal fractures treated with IMSF to those treated with CRPP patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate Receives: Procedure: CRPP |
| Intramedullary Screw Fixation | Experimental | we will compare proximal or middle phalangeal fractures treated with IMSF to those treated with CRPP patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate Receives: Procedure: IMSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Measure and compare Range of Motion pre and post operatively
Measured: from enrollment to the of end of the study at 12 months
Grip strength
Measure and compare grip strength, in Kilograms, pre and post operatively
Measured: from enrollment to the of end of the study at 12 months
Visual Analogue Scale for pain
The Visual Analog Scale (VAS) for pain is a standardized, subjective tool used to measure pain intensity. It consists of a straight 10-cm (100-mm) horizontal line anchored at one end by "no pain" and at the other by "the worst pain imaginable." Measure and compare patient reported VAS pre and post operatively.
Measured: from enrollment to the of end of the study at 12 months
Secondary outcomes (6)
Return to Work
Measure patient reported time to return to work in patients with phalangeal or metacarpal fractures treated with IMSF versus CRPP in phalangeal fractures and IMSF versus ORIF vs CRPP in metacarpal fractures respectively
Measured: from enrollment to the of end of the study at 12 months
Complications
Track complications that occur because of IMSF, ORIF, and CRPP in patients with surgically managed metacarpal or phalangeal fractures
Measured: from enrollment to the of end of the study at 12 months
Quick Dash,the Quick Disabilities of the Arm, Shoulder, and Hand
The Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire is a validated and widely used 11-item questionnaire that measures upper-extremity specific symptoms and disability. The main DASH uses a 5-point Likert scale (1 = no difficulty, 2 = mild, 3 = moderate, 4 = severe, 5 = unable)
Measured: from enrollment to the of end of the study at 12 months
Single assessment numeric evaluation (SANE)
Single assessment numeric evaluation (SANE) score assesses a patient's perceived overall function as a percentage of normal (0% to 100%), with higher scores indicating better function.
Measured: from enrollment to the of end of the study at 12 months
EuroQol 5-Dimensional questionnaire
The EuroQol 5-Dimensional questionnaire, EQ-5D, is a concise, generic measure of self-reported health which is accompanied by weights reflecting the relative importance to people of different types of health problems. It evaluates five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on 5 severity levels (no, slight, moderate, severe, and extreme/unable)) and utilizes an EQ VAS (Visual Analogue Scale) that allows patients to rate their overall health between 0 and 100
Measured: from enrollment to the of end of the study at 12 months
Patient-Rated Wrist/Hand Evaluation
PRW/HE is the Patient-Rated Wrist/Hand Evaluation. The PRW/HE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.
The PRW/HE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
Measured: from enrollment to the of end of the study at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metacarpal 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
- Model description
- Patients will be stratified based on fracture, metacarpals or phalanges. For the metacarpal group, we will use a1:1:1 randomization ratio (ORIF vs CRPP vs IMSF) using blocks of 9. For the phalangeal group, we will use a 1:1 ratio (CRPP vs IMSF) in blocks of 8.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spencer B Chambers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Spencer B Chambers, Western University
- Investigators
- Spencer B Chambers, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616947
- Sponsor's protocol ID
- 127846
- Other IDs
- 127846
- Acronym
- GRIP
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization in the Treatment of Phalangeal and Metacarpal Fractures: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07616947
- Acronym / sponsor ID
- GRIP / 127846
- Conditions
- Metacarpal Fracture, Phalanx Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Spencer B ChambersUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 1 Jun 2026 (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.
Broken bones in the hand are common injuries that can make it hard to move fingers, grip objects, and return to work. When these breaks happen in the long bones of the hand (called metacarpals and phalanges), surgery is often needed to hold the bones in the right place while they heal.
There are a few different ways surgeons can fix these broken bones. Two common methods are:
CRPP (Closed Reduction and Percutaneous Pinning): The bones are moved back into place without opening the skin, and thin metal pins are used to hold them.
IMSF (Intramedullary Screw Fixation): A small screw is placed inside the bone to hold it in position.
Another approach sometimes used for larger bones in the hand is ORIF (Open Reduction and Internal Fixation), where the bone is exposed through a small incision and held with plates or screws.
This study will compare how well these methods work. Investigators want to find out if using an intramedullary screw (IMSF) helps patients heal faster and move their hands more easily compared to the other common methods (CRPP and ORIF). Investigators will look at how quickly patients regain movement, how soon they can return to work, how satisfied they are with their recovery, and whether there are any problems or complications from surgery.
To do this, investigators will run a randomized controlled trial-this means patients will be stratified based on fracture location (metacarpals or phalanges) and randomly assigned to a treatment arm. For patients with metacarpal fractures, investigators will compare IMSF vs CRPP vs ORIF using a dorsal plate. For patients with proximal or middle phalangeal fractures investigators will compare IMSF to CRPP. Investigators will measure their recovery using both clinical tests and patient surveys over time. The results of this research will help surgeons choose the best and safest way to treat hand fractures so patients can heal faster and get back to their daily lives sooner
Detailed description
Metacarpal and phalangeal fractures are common traumatic injuries of the hand.1 Many can be treated conservatively, but when there is malalignment or instability, operative reduction and stabilization is required.2,3 Closed reduction and percutaneous pinning (CRPP), or open reduction and internal fixation (ORIF) using plates, screws, or wires are common methods of treatment.4-6 Percutaneous fixation allows stabilization of fractures with minimal soft tissue disruption,7-11 and although technically challenging, if successful, secondary complications such as tendon adhesions and abnormal scarring are uncommon.9 Conversely, open methods require broader exposure resulting in swelling and increased risk of scarring9, but facilitates early active motion allowing earlier return to function.3,10 Intramedullary screw fixation (IMSF) is a technique that is gaining popularity12,13 as it maintains the minimally invasive benefits of CRPP while providing stability similar to ORIF.14 In correctly selected fractures, IM screws facilitate early recovery with minimal down time, allowing expedited treatment and less loss of productivity.3,12,13 Investigators believe IM screws have notable advantages compared to CRPP. Allowing earlier rehabilitation, less external immobilization, and earlier functional recovery has potential to improve quality of life and reduce productivity loss.
These procedures are used currently within St. Joseph's Health Care London but there is debate regarding there efficacy and specific surgical technique varies amongst practitioners. The comparison comes between the specific surgical intervention, as although some surgeons have rapidly adapted this technique, is efficacy compared to more classic techniques has not been explored using high level studies, leaving its specific utility less clear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be stratified based on fracture, metacarpals or phalanges. For the metacarpal group, we will use a1:1:1 randomization ratio (ORIF vs CRPP vs IMSF) using blocks of 9. For the phalangeal group, we will use a 1:1 ratio (CRPP vs IMSF) in blocks of 8.
| Arm | Type | Receives |
|---|---|---|
| Open Reduction and Internal Fixation | Experimental | Procedure: ORIFpatients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate |
| Closed Reduction and Percutaneous Pinning | Experimental | Procedure: CRPPwe will compare proximal or middle phalangeal fractures treated with IMSF to those treated with CRPP patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate |
| Intramedullary Screw Fixation | Experimental | Procedure: IMSFwe will compare proximal or middle phalangeal fractures treated with IMSF to those treated with CRPP patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- surgical management within 10 days of injury
- extraarticular fractures, clinical scissoring
- sagittal angulation in accordance with accepted norms (Table 1)
- shortening >5mm, translation >50%.
- surgical management within 10 days of injury
Key exclusion criteria (4 listed)
- < 18 years old
- unable to read English, provide consent, or return to follow-up.
- Injuries with concomitant soft tissues loss, tendon injury, nerve injury, infection, or fractures with severe comminution
- history of prior surgical management of a fracture of the ipsilateral hand
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 |
|---|---|---|
| ORIFAlso: CRPPOpen Reduction and Internal Fixation | Procedure or surgery | Open Reduction and Internal Fixation |
| IMSFIntramedullary Screw Fixation | Procedure or surgery | Intramedullary Screw Fixation |
| CRPPClosed Reduction and Percutaneous Pinning | Procedure or surgery | Closed Reduction and Percutaneous Pinning |
Primary outcome
Range of Motion
Time frame: from enrollment to the of end of the study at 12 months
Measure and compare Range of Motion pre and post operatively
Grip strength
Time frame: from enrollment to the of end of the study at 12 months
Measure and compare grip strength, in Kilograms, pre and post operatively
Visual Analogue Scale for pain
Time frame: from enrollment to the of end of the study at 12 months
The Visual Analog Scale (VAS) for pain is a standardized, subjective tool used to measure pain intensity. It consists of a straight 10-cm (100-mm) horizontal line anchored at one end by "no pain" and at the other by "the worst pain imaginable." Measure and compare patient reported VAS pre and post operatively.
6 secondary outcomes
Return to Work
Time frame: from enrollment to the of end of the study at 12 months
Complications
Time frame: from enrollment to the of end of the study at 12 months
Quick Dash,the Quick Disabilities of the Arm, Shoulder, and Hand
Time frame: from enrollment to the of end of the study at 12 months
Single assessment numeric evaluation (SANE)
Time frame: from enrollment to the of end of the study at 12 months
EuroQol 5-Dimensional questionnaire
Time frame: from enrollment to the of end of the study at 12 months
Patient-Rated Wrist/Hand Evaluation
Time frame: from enrollment to the of end of the study at 12 months
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 1 Jun 2026.
- 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.
Spencer B Chambers principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORIF, IMSF and CRPP in people with Metacarpal Fracture and Phalanx Fracture, run by Spencer B Chambers at 1 site in Canada.
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 11 inclusion and 4 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Katrina Munro, MHIS (519-646-6100 ext. 64544, katrina.munro@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: from enrollment to the of end of the study at 12 months). The study lists 3 primary outcomes in all. 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 1 Jun 2026.