Immediate Weightbearing vs Delayed Weightbearing

Rehabilitation Clinical Trial

Official title:

Randomized Feasibility Trial for Immediate vs Delayed Weightbearing for Surgically Treated Fractures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05595148
• Other study ID #: HP-00103274
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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: 1. be able to enroll 50% of eligible patients and have a 90% follow-up at 90 days post-op of enrolled patients. 2. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Rehabilitation

Intervention

Procedure:
• Immediate WBAT
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.

Other:
• No Intervention: Delayed WBAT
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.

Locations

Country	Name	City	State
United States	University of Maryland, Shock Trauma Center	Baltimore	Maryland
United States	University of Maryland, Capital Region Health	Cheverly	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Gaski 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. — View Citation

Gitajn 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. — View Citation

Marchand 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with unplanned reoperation or hardware failure	Any reoperation associated with the enrolled fracture region (non union, malunion, hardware removal)	6 months following definitive fixation surgery
Secondary	Percentage of patients who maintained follow-up	Greater than 80% of enrolled patients maintained followup for 12 months following surgery	12 months following definitive fixation surgery