Trial Outcomes & Findings for Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures (NCT NCT03167099)

Results Overview

Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

up to 12 weeks

Results posted on

2022-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	Full Weight Bearing Participants assigned to full weight bearing after fixation of distal femur fracture.	Partial Weight Bearing Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Overall Study STARTED	26	27
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Weight Bearing n=26 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=26 Participants	0 Participants n=27 Participants	0 Participants n=53 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=26 Participants	6 Participants n=27 Participants	10 Participants n=53 Participants
Age, Categorical >=65 years	22 Participants n=26 Participants	21 Participants n=27 Participants	43 Participants n=53 Participants
Sex: Female, Male Female	23 Participants n=26 Participants	24 Participants n=27 Participants	47 Participants n=53 Participants
Sex: Female, Male Male	3 Participants n=26 Participants	3 Participants n=27 Participants	6 Participants n=53 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: up to 12 weeks

Population: Radiographic evidence not available for 4 subjects in each arm.

Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits.

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=22 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=23 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Time to Distal Femur Fracture Healing by Radiographic Evidence	1.75 months Standard Deviation 0.63	2.15 months Standard Deviation 0.87

SECONDARY outcome

Timeframe: up to 24 weeks

Population: Time to ambulation not collected for 7 participants in full weight bearing group; 8 participants in partial weight bearing group

Investigators measure time to ambulation

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=19 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=19 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Time to Ambulation	9.947 Weeks Interval 0.0 to 24.0	15.316 Weeks Interval 6.0 to 24.0

SECONDARY outcome

Timeframe: up to 1 year

Population: Data was not collected.

Investigators measure the length of time of physical therapy participation

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days

Investigators record the number of days from surgery to discharge

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=26 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Number of Days to Discharge	6.115 Days Interval 2.0 to 23.0	6.074 Days Interval 2.0 to 17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days

Investigators record the participants' discharge location, e.g. home, rehabilitation facility

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=26 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Discharge Disposition Home	5 Participants	5 Participants
Discharge Disposition Skilled Nursing Facility	10 Participants	18 Participants
Discharge Disposition Acute Rehab	10 Participants	4 Participants
Discharge Disposition Hospice/Comfort Measures Only	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months

Population: Data was not collected.

Investigators record the pain from 0-10 at each time point

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks, 3 months, 6 months, 12 months

Population: Data not collected.

Participants complete the Knee Society survey at the listed time points

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Knee flexion was not measured in 3 subjects in the full weight bearing group and 5 subjects in the partial weight bearing group.

Investigators measure knee flexion

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=23 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=22 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Knee Flexion	101 Degrees Interval 40.0 to 130.0	97 Degrees Interval 70.0 to 130.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Investigators assess non union at 1 year

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=26 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Number of Participants With Non Union	0 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Data was not collected.

Investigators assess malunion at 1 year

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Investigators check for infection

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=26 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Number of Participants With Infection	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Data was not collected.

Investigators check for Deep Vein Thrombosis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Investigators check for Pulmonary Embolism

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=26 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Number of Participants With Pulmonary Embolism	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Investigators check for implant failure at 12 months

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=26 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Number of Participants With Implant Failure	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months

Population: Data was not collected.

Investigators assess Vit D level in subject age 65 and older at all time points listed

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Investigators record any deaths at 12 months

Outcome measures

Outcome measures
Measure	Full Weight Bearing n=26 Participants Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 Participants Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Study Mortality	3 Participants	7 Participants

Adverse Events

Full Weight Bearing

Serious events: 2 serious events

Other events: 0 other events

Deaths: 3 deaths

Partial Weight Bearing

Serious events: 2 serious events

Other events: 1 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Full Weight Bearing n=26 participants at risk Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 participants at risk Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Product Issues Failure of Fixation	3.8% 1/26 • Number of events 1 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.	0.00% 0/27 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.
Musculoskeletal and connective tissue disorders Fracture from fall	3.8% 1/26 • Number of events 1 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.	0.00% 0/27 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.
Musculoskeletal and connective tissue disorders Nonunion	0.00% 0/26 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.	3.7% 1/27 • Number of events 1 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.
Musculoskeletal and connective tissue disorders Fall unknown source	0.00% 0/26 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.	3.7% 1/27 • Number of events 1 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.

Other adverse events

Other adverse events
Measure	Full Weight Bearing n=26 participants at risk Participants assigned to full weight bearing after fixation of distal femur fracture. Full Weight Bearing: Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.	Partial Weight Bearing n=27 participants at risk Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Respiratory, thoracic and mediastinal disorders COPD (Chronic Obstructive Pulmonary Disease)	0.00% 0/26 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.	3.7% 1/27 • Number of events 1 • 1 year from date of surgery Charts were reviewed at every clinic visit post operatively.

Additional Information

Dr. David Hubbard

West Virginia University

Phone: 304-293-3900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place