50 and older, any sex, with Intracapsular Proximal Femur Fracture or Garden Grade I Subcapital Fracture of Femoral Neck. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With a ReoperationPrimary· 12 months
Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
Group
Value
95% CI
N-Force Screws
0
Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)Secondary· 6 weeks, 3 months, 6 months, and 12 months
Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, lea
6 weeks - RUSH Healing
Group
Value
95% CI
N-Force Screws
5
3 months - RUSH Healing
Group
Value
95% CI
N-Force Screws
6
6 months - RUSH Healing
Group
Value
95% CI
N-Force Screws
5
12 months - RUSH Healing
Group
Value
95% CI
N-Force Screws
3
Participant Steinberg Classification at 12 MonthsSecondary· 12 months
Steinberg Classification is based on the radiographic appearance and location of lesion. It is concise and delineates the progression and extent of Avascular Necrosis (AVN) involvement more accurately.
\[stage 0:\] normal or non-diagnostic radiographs, MRI and bone scan of at risk hip (often contralateral hip involved, or patient has risk factors and hip pain) \[stage I:\] normal radiograph, abnormal bone scan and/or MRI \[stage II:\] cystic and sclerotic radiographic changes \[stage III:\] subchondral lucency or crescent sign \[stage IV:\] flattening of femoral head, with depression graded i
Stage 0: Normal radiographs
Group
Value
95% CI
N-Force Screws
1
Stage VI: Advanced degenerative changes
Group
Value
95% CI
N-Force Screws
1
Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)Secondary· 6 weeks, 3 months, 6 months, and 12 months
The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.
6 week - Fix-IT Score
Group
Value
95% CI
N-Force Screws
6.4
± 2.4
3 month - Fix-IT Score
Group
Value
95% CI
N-Force Screws
8.2
± 2.1
6 month - Fix-IT Score
Group
Value
95% CI
N-Force Screws
8.6
± 3.5
12 month - Fix-IT Score
Group
Value
95% CI
N-Force Screws
7
± 5.3
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)Secondary· 6 weeks, 3 months, 6 months, and 12 months
The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.
The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the wor
6 week - EQ-5D Score
Group
Value
95% CI
N-Force Screws
.605
± .257
3 month - EQ-5D Score
Group
Value
95% CI
N-Force Screws
.674
± .136
6 month - EQ-5D Score
Group
Value
95% CI
N-Force Screws
.719
± .131
12 month - EQ-5D Score
Group
Value
95% CI
N-Force Screws
.542
± .420
6 week - Health Status
Group
Value
95% CI
N-Force Screws
68.7
± 17.1
3 month - Health Status
Group
Value
95% CI
N-Force Screws
74.4
± 25.2
6 month - Health Status
Group
Value
95% CI
N-Force Screws
68
± 23.1
12 month - Health Status
Group
Value
95% CI
N-Force Screws
78.3
± 2.9
Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)Secondary· 6 weeks, 3 months, 6 months, and 12 months
This will be measured using Harris Hip Score. This is quantified on a scale of 0-100 and the domains covered are pain, function, absence of deformity, and range of motion. The score is quantified on a scale of 0-100, with 100 points being the best possible outcome. The domains cover pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
6 weeks - Harris Hip Score
Group
Value
95% CI
N-Force Screws
55.7
± 16
3 months - Harris Hip Score
Group
Value
95% CI
N-Force Screws
59.3
± 17.6
6 months - Harris Hip Score
Group
Value
95% CI
N-Force Screws
65.4
± 15.7
12 months - Harris Hip Score
Group
Value
95% CI
N-Force Screws
68.7
± 28.7
Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)Secondary· 6 weeks, 3 months, 6 months, and 12 months
This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be pr
6 Week - Did Patient perform test?
Group
Value
95% CI
N-Force Screws
5
3 Month - Did Patient perform test?
Group
Value
95% CI
N-Force Screws
6
6 Month - Did Patient perform test?
Group
Value
95% CI
N-Force Screws
4
1 Year - Did Patient perform test?
Group
Value
95% CI
N-Force Screws
1
Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)Secondary· 6 weeks, 3 months, 6 months, and 12 months
This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be pr
6 Week - Average Time to Complete Test (seconds)
Group
Value
95% CI
N-Force Screws
21.8
± 9.5
3 Month - Average Time to Complete Test (seconds)
Group
Value
95% CI
N-Force Screws
35.3
± 39.9
6 Month - Average Time to Complete Test (seconds)
Group
Value
95% CI
N-Force Screws
15.5
± 7
1 Year - Average Time to Complete Test (seconds)
Group
Value
95% CI
N-Force Screws
11
± 0
Adverse events — posted to ClinicalTrials.gov
Time frame: Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zimmer Biomet
Last refreshed: 8 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03807349.