RehabilitationNCT05595148
Immediate Weightbearing vs Delayed Weightbearing
A study testing Immediate WBAT in people with Rehabilitation, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The purpose of this study is to perform a feasibility trial of immediate versus delayed weight bearing following fixation of fractures of the lower extremity, pelvis, and acetabulum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Immediate WBAT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2023to Dec 2026
- 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
- Fracture of the acetabulum, pelvis, distal femur, distal tibia, including those with intra- articular extension, that meets surgical indications.
- Operative treatment within 7 days of injury at R Adams Cowley Shock Trauma Center, University of Maryland, University of Maryland Medical System, University of Maryland Capital Region Medical Center.
- Provision of informed consent.
Who cannot join
- Non English Speaking.
- Cognitive ability does not allow for full understanding of study procedures ( Patient has been diagnosed with psychiatric condition, intellectually challenged without adequate family support).
- Patient has other orthopaedic or non-orthopaedic injuries that would preclude him/her from being able to weight bear immediately (e.g. open fractures, polytrauma.
- Significant impaction (>2mm) or comminution at joint surface (e.g. with acetabulum, distal femur, tibial plateau, or tibial plafond fractures).
- Patients who would not be able to immediately weight bear or comply with weight bearing restrictions.
- Not willing to be randomized.
- Surgeon or clinical follow will not occur at participating hospital or location.
- Anticipated problems with follow up in the judgement of study personnel ( patient is homeless).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Maryland, Shock Trauma Center
Baltimore, Maryland, 21201
University of Maryland, Capital Region Health
Cheverly, Maryland, 20785
About this study
Official title: Randomized Feasibility Trial for Immediate vs Delayed Weightbearing for Surgically Treated Fractures
The purpose of this study is to perform a feasibility trial of immediate versus delayed weight bearing following fixation of fractures of the lower extremity, pelvis, and acetabulum. The investigator will enroll patients from Shock Trauma over a period of 12 months, and randomize them to immediate weight bearing as tolerated (WBAT) versus delayed WBAT (non-weightbearing for 6-12 weeks). Four specific feasibility criteria will be assessed: enrollment (target 50%), follow-up (target 90% at 3 months), correct documentation of weight bearing (target 90%), correct documentation of primary outcomes, which include reoperation and hardware failure (target 90%). Target enrollment is patients with fractures where the current standard of care is delayed WBAT; for lower extremity this will include fractures of the distal femur, proximal tibia, and distal tibia, including select fractures with intra-articular extension. If feasibility criteria are met over the course of this study, the investigator hopes to move forward with a multicenter randomized controlled trial on this topic.
Read the detailed description
Weight bearing restrictions are increasingly being scrutinized, as understanding of the potential negative effects of immobilization expand. Recent studies have highlighted that early WBAT may be safe following fixation of lower extremity, pelvis, and acetabulum fractures where the standard of care has been delayed WBAT, but high-quality prospective studies on this topic are needed.
The investigator hypothesizes that in a feasibility trial of immediate versus delayed WBAT following lower extremity, pelvis, and acetabulum fracture fixation, this trial will:
- be able to enroll 50% of eligible patients and have a 90% follow-up at 90 days post-op of enrolled patients.
- be able to achieve 90% correct documentation of postoperative weight bearing status and primary outcomes (reoperation or hardware failure).
Specific Aim 1 - Evaluate in a feasibility trial of immediate versus delayed WBAT following lower extremity, pelvis, and acetabulum fracture fixation whether 50% of patients can be enrolled, and 90% of those enrolled will have 90-day follow-up.
Specific Aim 2 - Evaluate in a feasibility trial of immediate versus delayed WBAT following lower extremity, pelvis, and acetabulum fracture fixation whether 90% correct documentation of postoperative weight bearing status and 90% correct documentation of primary outcomes (reoperation or hardware failure) can be obtained.
The investigator anticipates that the feasibility criteria will be met with regard to enrollment, follow-up, and documentation, which will allow us to begin a (likely multicenter) randomized controlled trial evaluating early versus delayed weight bearing following lower extremity, pelvis, and acetabulum fixation.
- Conditions
- Rehabilitation
- Being tested
- Immediate WBAT, No Intervention: Delayed WBAT
- Keywords
- Feasibility, Orthopaedic trauma, randomized care, WBAT, Delayed weightbearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate WBATProcedure or surgery
Men or women over 18 years who present with a fracture of the acetabulum, pelvis, distal femur, proximal tibia, distal tibia, who will undergo fracture fixation within 7 days of their injury and consent to the research study.
No Intervention: Delayed WBATOther
Patients with ankle fractures will be instructed to touch-down (toe touch or foot flat) weight bear (approximately 10% of body weight) while in the boot for. Patients will be instructed to keep foot off of floor or set ball of foot or heal on ground for balance using walker or crutches at all times. After the 6 week post op visit, patients may begin weight bearing as tolerated. Patients with tibial plateau fractures will be instructed to touch down (toe touch or foot flat) weight bear (approximately 10% of body weight) for at least 6 weeks. After the 6 week post op visit, patients may begin weight bearing as tolerated until full weight bearing is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Immediate WBAT | Active comparator | Recent studies have highlighted that early WBAT is may be safe following fixation of lower extremity, pelvis, and acetabulum fractures where the standard of care has been delayed WBAT, but high-quality prospective studies on this topic are needed. Receives: Procedure: Immediate WBAT |
| Delayed WBAT | Active comparator | Though immediate postoperative WBAT has become the standard of care following fixation of pertrochanteric, femoral shaft, and tibial shaft fractures, most surgeons restrict patient weight bearing following fixation of other lower extremity and pelvis/acetabulum fractures. Progression to full weight bearing varies greatly by type of fracture, fixation method, and surgeon. Weight bearing restrictions following fracture fixation have been shown to be associated with various poor outcomes (increased complications, prolonged hospital length of stay, etc.), particularly in geriatric patients. Thus, it is important for us to understand if it is safe to allow early weight bearing following lower extremity and pelvis/acetabulum fracture fixation, as this could help expedite patient mobility and return to function, and potentially reduce complications. Receives: Other: No Intervention: Delayed WBAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with unplanned reoperation or hardware failure
Any reoperation associated with the enrolled fracture region (non union, malunion, hardware removal)
Measured: 6 months following definitive fixation surgery
Secondary outcomes (1)
Percentage of patients who maintained follow-up
Greater than 80% of enrolled patients maintained followup for 12 months following surgery
Measured: 12 months following definitive fixation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start10 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert O'Toole, University of Maryland, Baltimore
- Investigators
- Robert O'Toole, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595148
- Sponsor's protocol ID
- HP-00103274
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2022
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cunningham BP, Ali A, Parikh HR, Heare A, Blaschke B, Zaman S, Montalvo R, Reahl B, Rotuno G, Kark J, Bender M, Miller B, Basmajian H, McLemore R, Shearer DW, Obremskey W, Sagi C, O'Toole RV. Immediate weight bearing as tolerated (WBAT) correlates with a decreased length of stay post intramedullary fixation for subtrochanteric fractures: a multicenter retrospective cohort study. Eur J Orthop Surg Traumatol. 2021 Feb;31(2):235-243. doi: 10.1007/s00590-020-02759-3. Epub 2020 Aug 14.
PubMed 32797351Gaski GE, Manson TT, Castillo RC, Slobogean GP, O'Toole RV. Nonoperative treatment of intermediate severity lateral compression type 1 pelvic ring injuries with minimally displaced complete sacral fracture. J Orthop Trauma. 2014 Dec;28(12):674-80. doi: 10.1097/BOT.0000000000000130.
PubMed 24740110Gitajn IL, Connelly D, Mascarenhas D, Breazeale S, Berger P, Schoonover C, Martin B, O'Toole RV, Pensy R, Sciadini M. Is prescribed lower extremity weight-bearing status after geriatric lower extremity trauma associated with increased mortality? Injury. 2018 Feb;49(2):404-408. doi: 10.1016/j.injury.2017.12.012. Epub 2017 Dec 14.
PubMed 29249533Marchand LS, Horton S, Mullike A, Goel R, Krum N, Ochenjele G, O'Hara N, O'Toole RV, Eglseder WA, Pensy R. Immediate Weight Bearing of Plated Both-Bone Forearm Fractures Using Eight Cortices Proximal and Distal to the Fracture in the Polytrauma Patient Is Safe. J Am Acad Orthop Surg. 2021 Aug 1;29(15):666-672. doi: 10.5435/JAAOS-D-20-01252.
PubMed 34030171Mittwede PN, Li V, Okhuereigbe DO, Bell AC, Loudermilk C, Demyanovich HK, Lawrence JE, Turner KE, Kovvur M, Brand JP, Cunningham DJ, Johnson DJ, Sepehri A, Sciadini MF, Nascone JW, Gage MJ, Hempen EC, O'Hara NN, Slobogean GP, O'Toole RV. Immediate versus delayed weight bearing for fractures of the pelvis, acetabulum, distal femur, and proximal and distal tibia: a feasibility randomized controlled trial. Pilot Feasibility Stud. 2025 Nov 5;11(1):133. doi: 10.1186/s40814-025-01708-3.
PubMed 41194216
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Feasibility Trial for Immediate vs Delayed Weightbearing for Surgically Treated Fractures
- ClinicalTrials.gov ID
- NCT05595148
- Acronym / sponsor ID
- HP-00103274
- Conditions
- Rehabilitation
- Keywords
- Feasibility, Orthopaedic trauma, randomized care, WBAT, Delayed weightbearing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Oct 2022 (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.
The purpose of this study is to perform a feasibility trial of immediate versus delayed weight bearing following fixation of fractures of the lower extremity, pelvis, and acetabulum. The investigator will enroll patients from Shock Trauma over a period of 12 months, and randomize them to immediate weight bearing as tolerated (WBAT) versus delayed WBAT (non-weightbearing for 6-12 weeks). Four specific feasibility criteria will be assessed: enrollment (target 50%), follow-up (target 90% at 3 months), correct documentation of weight bearing (target 90%), correct documentation of primary outcomes, which include reoperation and hardware failure (target 90%). Target enrollment is patients with fractures where the current standard of care is delayed WBAT; for lower extremity this will include fractures of the distal femur, proximal tibia, and distal tibia, including select fractures with intra-articular extension. If feasibility criteria are met over the course of this study, the investigator hopes to move forward with a multicenter randomized controlled trial on this topic.
Detailed description
Weight bearing restrictions are increasingly being scrutinized, as understanding of the potential negative effects of immobilization expand. Recent studies have highlighted that early WBAT may be safe following fixation of lower extremity, pelvis, and acetabulum fractures where the standard of care has been delayed WBAT, but high-quality prospective studies on this topic are needed.
The investigator hypothesizes that in a feasibility trial of immediate versus delayed WBAT following lower extremity, pelvis, and acetabulum fracture fixation, this trial will:
- be able to enroll 50% of eligible patients and have a 90% follow-up at 90 days post-op of enrolled patients.
- be able to achieve 90% correct documentation of postoperative weight bearing status and primary outcomes (reoperation or hardware failure).
Specific Aim 1 - Evaluate in a feasibility trial of immediate versus delayed WBAT following lower extremity, pelvis, and acetabulum fracture fixation whether 50% of patients can be enrolled, and 90% of those enrolled will have 90-day follow-up.
Specific Aim 2 - Evaluate in a feasibility trial of immediate versus delayed WBAT following lower extremity, pelvis, and acetabulum fracture fixation whether 90% correct documentation of postoperative weight bearing status and 90% correct documentation of primary outcomes (reoperation or hardware failure) can be obtained.
The investigator anticipates that the feasibility criteria will be met with regard to enrollment, follow-up, and documentation, which will allow us to begin a (likely multicenter) randomized controlled trial evaluating early versus delayed weight bearing following lower extremity, pelvis, and acetabulum fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate WBAT | Active comparator | Procedure: Immediate WBATRecent studies have highlighted that early WBAT is may be safe following fixation of lower extremity, pelvis, and acetabulum fractures where the standard of care has been delayed WBAT, but high-quality prospective studies on this topic are needed. |
| Delayed WBAT | Active comparator | Other: No Intervention: Delayed WBATThough immediate postoperative WBAT has become the standard of care following fixation of pertrochanteric, femoral shaft, and tibial shaft fractures, most surgeons restrict patient weight bearing following fixation of other lower extremity and pelvis/acetabulum fractures. Progression to full weight bearing varies greatly by type of fracture, fixation method, and surgeon. Weight bearing restrictions following fracture fixation have been shown to be associated with various poor outcomes (increased complications, prolonged hospital length of stay, etc.), particularly in geriatric patients. Thus, it is important for us to understand if it is safe to allow early weight bearing following lower extremity and pelvis/acetabulum fracture fixation, as this could help expedite patient mobility and return to function, and potentially reduce complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fracture of the acetabulum, pelvis, distal femur, distal tibia, including those with intra- articular extension, that meets surgical indications.
- Operative treatment within 7 days of injury at R Adams Cowley Shock Trauma Center, University of Maryland, University of Maryland Medical System, University of Maryland Capital Region Medical Center.
- Provision of informed consent.
Key exclusion criteria (8 listed)
- Non English Speaking.
- Cognitive ability does not allow for full understanding of study procedures ( Patient has been diagnosed with psychiatric condition, intellectually challenged without adequate family support).
- Patient has other orthopaedic or non-orthopaedic injuries that would preclude him/her from being able to weight bear immediately (e.g. open fractures, polytrauma.
- Significant impaction (>2mm) or comminution at joint surface (e.g. with acetabulum, distal femur, tibial plateau, or tibial plafond fractures).
- Patients who would not be able to immediately weight bear or comply with weight bearing restrictions.
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 |
|---|---|---|
| Immediate WBATMen or women over 18 years who present with a fracture of the acetabulum, pelvis, distal femur, proximal tibia, distal tibia, who will undergo fracture fixation within 7 days of their injury and consent to the research study. | Procedure or surgery | Immediate WBAT |
| No Intervention: Delayed WBATPatients with ankle fractures will be instructed to touch-down (toe touch or foot flat) weight bear (approximately 10% of body weight) while in the boot for. Patients will be instructed to keep foot off of floor or set ball of foot or heal on ground for balance using walker or crutches at all times. After the 6 week post op visit, patients may begin weight bearing as tolerated. Patients with tibial plateau fractures will be instructed to touch down (toe touch or foot flat) weight bear (approximately 10% of body weight) for at least 6 weeks. After the 6 week post op visit, patients may begin weight bearing as tolerated until full weight bearing is achieved. | Other | Delayed WBAT |
Primary outcome
The number of participants with unplanned reoperation or hardware failure
Time frame: 6 months following definitive fixation surgery
Any reoperation associated with the enrolled fracture region (non union, malunion, hardware removal)
1 secondary outcome
Percentage of patients who maintained follow-up
Time frame: 12 months following definitive fixation surgery
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 26 Jan 2026.
- Background: PubMed 32797351Cunningham BP, Ali A, Parikh HR, Heare A, Blaschke B, Zaman S, Montalvo R, Reahl B, Rotuno G, Kark J, Bender M, Miller B, Basmajian H, McLemore R, Shearer DW, Obremskey W, Sagi C, O'Toole RV. Immediate weight bearing as tolerated (WBAT) correlates with a decreased length of stay post intramedullary fixation for subtrochanteric fractures: a multicenter retrospective cohort study. Eur J Orthop Surg Traumatol. 2021 Feb;31(2):235-243. doi: 10.1007/s00590-020-02759-3. Epub 2020 Aug 14.
- Background: PubMed 24740110Gaski GE, Manson TT, Castillo RC, Slobogean GP, O'Toole RV. Nonoperative treatment of intermediate severity lateral compression type 1 pelvic ring injuries with minimally displaced complete sacral fracture. J Orthop Trauma. 2014 Dec;28(12):674-80. doi: 10.1097/BOT.0000000000000130.
- Background: PubMed 29249533Gitajn IL, Connelly D, Mascarenhas D, Breazeale S, Berger P, Schoonover C, Martin B, O'Toole RV, Pensy R, Sciadini M. Is prescribed lower extremity weight-bearing status after geriatric lower extremity trauma associated with increased mortality? Injury. 2018 Feb;49(2):404-408. doi: 10.1016/j.injury.2017.12.012. Epub 2017 Dec 14.
- Background: PubMed 34030171Marchand LS, Horton S, Mullike A, Goel R, Krum N, Ochenjele G, O'Hara N, O'Toole RV, Eglseder WA, Pensy R. Immediate Weight Bearing of Plated Both-Bone Forearm Fractures Using Eight Cortices Proximal and Distal to the Fracture in the Polytrauma Patient Is Safe. J Am Acad Orthop Surg. 2021 Aug 1;29(15):666-672. doi: 10.5435/JAAOS-D-20-01252.
- Derived from this study: PubMed 41194216Mittwede PN, Li V, Okhuereigbe DO, Bell AC, Loudermilk C, Demyanovich HK, Lawrence JE, Turner KE, Kovvur M, Brand JP, Cunningham DJ, Johnson DJ, Sepehri A, Sciadini MF, Nascone JW, Gage MJ, Hempen EC, O'Hara NN, Slobogean GP, O'Toole RV. Immediate versus delayed weight bearing for fractures of the pelvis, acetabulum, distal femur, and proximal and distal tibia: a feasibility randomized controlled trial. Pilot Feasibility Stud. 2025 Nov 5;11(1):133. doi: 10.1186/s40814-025-01708-3.
- 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.
Robert O'Toole, MD principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate WBAT in people with Rehabilitation, run by University of Maryland, Baltimore at 2 sites in United States.
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 3 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with unplanned reoperation or hardware failure (time frame: 6 months following definitive fixation surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595148, which also lists 5 linked publications.
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 26 Jan 2026.