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老年性大腿骨遠位部

2026年9月29日 更新者:Wake Forest University Health Sciences

高齢患者における大腿骨遠位部関節外および完全関節内骨折に対する単一インプラント固定と二重インプラント固定の比較

The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Fractures of the distal femur are severe and common injuries sustained by older adults. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to activities of daily living and impacts quality of life. Despite numerous studies of a variety of different surgical treatment strategies, the incidence of nonunion remains high. Therefore, any novel strategy to reduce the risk of nonunion and accelerate return to activities after distal femur fracture warrants rigorous study. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.

研究の種類

介入

入学 (推定)

256

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • North Carolina
      • Charlotte、North Carolina、アメリカ、28204
        • 募集
        • Atrium Health

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

55年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Age greater than or equal to 55 years
  • Surgically treated displaced distal femur extra articular or complete articular fractures

Exclusion Criteria:

  • Patients with injury features that preclude treatment with 2 implants
  • Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
  • Body Mass Index (BMI) > 40
  • Injury due to ground level fall
  • Patient that speaks neither English or Spanish
  • Patients with multisystem injuries that could preclude return to work
  • < 55 years of age
  • Prisoner

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
他の:Single Implant Fixation

Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail which is the current standard of care.

Lateral precontoured 4.5 mm distal femur plate or an intramedullary nail at the surgeon's discretion. Standard-of-care techniques will be used by the surgeon for fracture reduction and implant placement.

他の:Dual Implant Fixation

Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate which is the current standard of care.

Lateral precontoured distal femur plate and either (1) an intramedullary nail or (2) a medial plate. The medial plate must span the extra-articular portion of the fracture and must have stiffness of a 3.5 mm reconstruction plate, 3.5 mm limited contact dynamic compression plate, or greater.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Unions
時間枠:6-week, 3, 6, 12 months

Union, as determined by the treating surgeon, will be assessed via radiographs and documented as a dichotomous outcome (yes/no), and time to union will also be captured. Nonunion will be captured via surgeon diagnosis or return to the operating room for nonunion treatment.

6-week, 3, 6, 12 months
Total Surgical Time - Reoperations
時間枠:6-week, 3, 6, 12 months

The total surgical time during any reoperations will be collected from the medical record.

6-week, 3, 6, 12 months
Number of Reoperations
時間枠:6-week, 3, 6, 12 months

Details regarding reoperations will also be collected, whether or not the operation results in an inpatient admission.

6-week, 3, 6, 12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Resource Utilizations
時間枠:6-week, 3, 6, 12 month

Healthcare utilization, including all hospitalizations, emergency department visits, clinic visits, imaging, and physical therapy sessions after the index stay following injury will be documented at all follow-up visits.

6-week, 3, 6, 12 month
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
時間枠:Week 6

Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.

Week 6
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
時間枠:Month 3

Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.

Month 3
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
時間枠:Month 6

Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.

Month 6
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
時間枠:Month 12

Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.

Month 12
Time to Walking Without an Assistive Device
時間枠:6-week, 3, 6, 12 months

Use of an assistive device will be abstracted from the medical record and/or collected via patient interview at each follow up time point.

6-week, 3, 6, 12 months
Prescribed Weight Bearing Status
時間枠:6-week, 3, 6, 12 months

The prescribed weightbearing status will be captured from discharge instructions and clinic notes.

6-week, 3, 6, 12 months
Fear of Movement -Tampa Scale for Kinesiophobia (TSK) Scores
時間枠:6-week, 3, 6, 12 months

Tampa Scale for Kinesiophobia (TSK) will be utilized to measure fear of movement. This scale is 17 items and uses a 4-point Likert scale ranging from 'strongly disagree' to 'strongly agree'. The TSK is a validated measure for surgical and musculoskeletal patients. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.

6-week, 3, 6, 12 months
Health Related Quality of Life - Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
時間枠:6-week, 3, 6, 12 months

The PROMIS-29 includes seven domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. A 5-point Likert scale is used for each question and norm-based total scores (range 0-100) have been calculated so that 50 represents the mean and one standard deviation is 10 points. Higher scores represent better function.

6-week, 3, 6, 12 months
Global Health Status - Veterans RAND 12 Item Health Survey (VR12) Scores
時間枠:6-week, 3, 6, 12 months

The VR-12 is a measure of global health that corresponds to seven domains: general health, physical functioning, role limitations, pain, fatigue, social functioning, and mental health. Scores range from 0 to 100. 0 indicates the lowest level of health and 100 indicates the highest level of health.

6-week, 3, 6, 12 months
Work Productivity and Activity Impairment Questionnaire Scores
時間枠:6-week, 3, 6, 12 months

The Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire is an instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

6-week, 3, 6, 12 months
Numeric Pain Rating
時間枠:6-week, 3, 6, 12 months

Patients will be asked to rate their current pain on a visual analog scale. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.

6-week, 3, 6, 12 months
Pain Inventory (BPI)
時間枠:6-week, 3, 6, 12 months

Pain will be assessed using the Brief Pain Inventory (BPI). The BPI is a commonly used and validated 15-item measure of pain intensity and interference with daily life. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain. Higher scores meaning higher pain.

6-week, 3, 6, 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference
時間枠:6-week, 3, 6, 12 months

The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation - scores (range 0-100). Higher scores means a higher level of pain interference.

6-week, 3, 6, 12 months
Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) Classification
時間枠:1 year

If PTOA is present, Kellgren Lawrence (KL) classification will be assessed by the panel of reviewers and documented. Higher scores represent worse PTOA. Grade 0 - Normal articular cartilage. Grade I - Softening and swelling. Grade II - Fragmentation and fissuring of less than 0.5 inches. Grade III - Fragmentation and fissuring of greater than 0.5 inches. Grade IV - Erosion down to the subchondral bone.

1 year
Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS)
時間枠:1 year

If PTOA is present, the Paley Grading System (PGS) will be assessed by the panel of reviewers and documented. Higher scores represent worse PTOA. Standard joint space with no evidence of degeneration was set as Grade 0. Normal joint space with the occurrence of osteophytes, subchondral sclerosis, and cysts was set as Grade 1. Joint space narrowing was set as Grade 2. Disappeared joint space was set as Grade 3.

1 year
Geriatric Depression Scale
時間枠:6-week, 3, 6, 12 months

This scale has been validated in many studies and is unique in that it is tailored to a geriatric population by distinguishing between undiagnosed dementia and depression. Patients will also complete this scale to measure depression as part of health-related quality of life. The Geriatric Depression Scale (GDS) includes a total score range of 0 to 15. A score of 5 or more suggests depression. A score of 6 on this scale has a 94% sensitivity and 85% specificity for Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosed depression.

6-week, 3, 6, 12 months
Morphine Milligram Equivalents (MME)
時間枠:6-week, 3, 6, 12 months

To evaluate pain medication as a confounder to pain scores and complications MME will be calculated at each time point. To assess MME as a confounder, MME will be compared by treatment group at each time point.

6-week, 3, 6, 12 months
Total Surgical Time - Index Surgery
時間枠:Baseline

The total surgical time during the index surgery will be collected from the medical record

Baseline
Total Hospital Days
時間枠:Baseline, 6-week, 3, 6, 12 months

Total hospital days, including the index hospitalization and any subsequent inpatient stays will be captured

Baseline, 6-week, 3, 6, 12 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Laurence Kempton, M.D.、Wake Forest University Health Sciences

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月23日

一次修了 (推定)

2028年12月1日

研究の完了 (推定)

2029年12月1日

試験登録日

最初に提出

2025年11月14日

QC基準を満たした最初の提出物

2025年11月14日

最初の投稿 (実際)

2025年11月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月30日

QC基準を満たした最後の更新が送信されました

2026年9月29日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IRB00139405

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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