Bony Weight Bearing DisorderNCT06329271
After Hip Fracture Nailing, Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR)
A study testing Early-Weight bearing in people with Bony Weight Bearing Disorder, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bony Weight Bearing Disorder
- What is being tested?
- Early-Weight bearing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2024to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients with AO/OTA type 31 fractures were included, and all fractures were classified using intraoperative fluoroscopy with traction on the fracture table.
Who cannot join
- Patients with pathological fractures, neurovascular insufficiency, ipsilateral lower extremity musculoskeletal injury, multiple fractures, or high risk of falling, including frequent falling accidents within 6 months, unsteady gait, ipsilateral neuropathy, limb weakness, and urinary incontinence were excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far-Eastern Memorial Hospital
New Taipei City, 220
Yen Cheng Chen, 886919207805, sstteevveepp@gmail.com
About this study
Official title: Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR) After Hip Fracture Nailing,
Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.
Patients and methods:
For this prospective single-center clinical trial study, we recruited 60 geriatric proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. The participants were assigned to the Early-weight-bearing group (n= 30) or the Weight-bearing restriction group (n = 30). Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded.
- Conditions
- Bony Weight Bearing Disorder
- Being tested
- Early-Weight bearing
- Keywords
- fracture reduction, proximal femur fracture, geriatrics, early weight-bearing
- Medical subject headings
- Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early-Weight bearingBehavioural
The patients began early weight bearing under attending physician and physiotherapist surveillance within 48 hours after surgery. Patients were instructed to stand up near the bed, and muscle power, gait stability, and pain tolerance were recorded. The physiotherapist instructed the patients to perform early mobilization and weight bearing as tolerable by self-adjustment of body weight distribution over the bilateral lower extremities, and walking assistance was used to prevent repeat falling accidents.
| Study group | Role | What they receive |
|---|---|---|
| Early-Weight bearing | Experimental | Early Weight bearing was defined as starting Weight bearing within 48 h postoperatively, and WBAT referred to the adjustment of fracture site weight-bearing by pain tolerance. Receives: Behavioral: Early-Weight bearing |
| Weight-bearing restriction | No intervention | Weight bearing as toleration started after 48 h postoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Functional score
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
Measured: Functional and radiographic evaluations was performed at week 1 postoperatively
Harris Hip Functional score
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
Measured: Functional and radiographic evaluations was performed at months 1 postoperatively
Harris Hip Functional score
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
Measured: Functional and radiographic evaluations was performed at months 3 postoperatively
Harris Hip Functional score
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
Measured: Functional and radiographic evaluations was performed at months 6 postoperatively
Harris Hip Functional score
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
Measured: Functional and radiographic evaluations was performed at months 12 postoperatively
Secondary outcomes (6)
Visual analog pain score
Independent assessor (VAS:0-10, higher scores mean a worse outcome)
Measured: Record at week 1 postoperatively
Visual analog pain score
Independent assessor (VAS:0-10, higher scores mean a worse outcome)
Measured: Record at months 1 postoperatively
Visual analog pain score
Independent assessor (VAS:0-10, higher scores mean a worse outcome)
Measured: Record at months 3 postoperatively
Visual analog pain score
Independent assessor (VAS:0-10, higher scores mean a worse outcome)
Measured: Record at months 6 postoperatively
Visual analog pain score
Independent assessor (VAS:0-10, higher scores mean a worse outcome)
Measured: Record at months 12 postoperatively
Complication
Loss of reduction, malunion, nonunion or medical complications
Measured: Functional and radiographic evaluations were performed at week 1, months 1, 3, 6, and 12 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start8 Mar 2024
- Primary completion29 Apr 2025 (estimated)
- Study completion29 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bony Weight Bearing DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329271
- Sponsor's protocol ID
- 113022-E
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR) After Hip Fracture Nailing,
- ClinicalTrials.gov ID
- NCT06329271
- Acronym / sponsor ID
- 113022-E
- Conditions
- Bony Weight Bearing Disorder
- Keywords
- fracture reduction, proximal femur fracture, geriatrics, early weight-bearing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 29 Apr 2025 (estimated)
- Study completion
- 29 Apr 2025 (estimated)
- First posted
- 25 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.
Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.
Patients and methods:
For this prospective single-center clinical trial study, we recruited 60 geriatric proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. The participants were assigned to the Early-weight-bearing group (n= 30) or the Weight-bearing restriction group (n = 30). Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-Weight bearing | Experimental | Behavioral: Early-Weight bearingEarly Weight bearing was defined as starting Weight bearing within 48 h postoperatively, and WBAT referred to the adjustment of fracture site weight-bearing by pain tolerance. |
| Weight-bearing restriction | No intervention | –Weight bearing as toleration started after 48 h postoperatively. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients with AO/OTA type 31 fractures were included, and all fractures were classified using intraoperative fluoroscopy with traction on the fracture table.
Key exclusion criteria (1 listed)
- Patients with pathological fractures, neurovascular insufficiency, ipsilateral lower extremity musculoskeletal injury, multiple fractures, or high risk of falling, including frequent falling accidents within 6 months, unsteady gait, ipsilateral neuropathy, limb weakness, and urinary incontinence were excluded.
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 |
|---|---|---|
| Early-Weight bearingThe patients began early weight bearing under attending physician and physiotherapist surveillance within 48 hours after surgery. Patients were instructed to stand up near the bed, and muscle power, gait stability, and pain tolerance were recorded. The physiotherapist instructed the patients to perform early mobilization and weight bearing as tolerable by self-adjustment of body weight distribution over the bilateral lower extremities, and walking assistance was used to prevent repeat falling accidents. | Behavioural | Early-Weight bearing |
Primary outcome
Harris Hip Functional score
Time frame: Functional and radiographic evaluations was performed at week 1 postoperatively
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
Harris Hip Functional score
Time frame: Functional and radiographic evaluations was performed at months 1 postoperatively
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
Harris Hip Functional score
Time frame: Functional and radiographic evaluations was performed at months 3 postoperatively
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
Harris Hip Functional score
Time frame: Functional and radiographic evaluations was performed at months 6 postoperatively
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
Harris Hip Functional score
Time frame: Functional and radiographic evaluations was performed at months 12 postoperatively
The questionaire to patient. (HHS score 0-100,<60 poor,>80 good)
6 secondary outcomes
Visual analog pain score
Time frame: Record at week 1 postoperatively
Visual analog pain score
Time frame: Record at months 1 postoperatively
Visual analog pain score
Time frame: Record at months 3 postoperatively
Visual analog pain score
Time frame: Record at months 6 postoperatively
Visual analog pain score
Time frame: Record at months 12 postoperatively
Complication
Time frame: Functional and radiographic evaluations were performed at week 1, months 1, 3, 6, and 12 postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early-Weight bearing in people with Bony Weight Bearing Disorder, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen Cheng Chen, Doctor (886-919207805, sstteevveepp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Functional score (time frame: Functional and radiographic evaluations was performed at week 1 postoperatively). The study lists 5 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 25 Mar 2024.