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Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

2015年5月26日 更新者：Synthes GmbH
Case series of tibial plateau fractures using Norian Drillable.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This study is a multi-center, non-randomized prospective case series of tibial plateau fractures using Norian Drillable to fill bone voids, to evaluate OR time, blood loss, complications, ease of use, fracture stabilization and patient function and pain over time.

研究の種類

観察的

入学 (実際)

33

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。

研究場所

  • オランダ
      • Nieuwegein、オランダ、3435
        • St. Antonius Ziekenhuis
      • Tilburg、オランダ、5022
        • St. Elisabeth Ziekenhuis
  • オーストラリア
    • New South Wales
      • Liverpool、New South Wales、オーストラリア、2170
        • Liverpool Hospital
      • New Lambton、New South Wales、オーストラリア、2305
        • John Hunter Hospital
  • ノルウェー
      • Tønsberg、ノルウェー、3103
        • Sykehuset I Vestfold
  • 中国
      • Hong Kong、中国
        • Queen Mary Hospital

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

18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

サンプリング方法

非確率サンプル

調査対象母集団

Primary care clinic

説明

Inclusion Criteria:

  • Subjects with closed tibial plateau fractures classified as OTA B2, B3 or C3 resulting in a bone void.
  • At least 18 years of age.
  • Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
  • Signed informed consent.

Exclusion Criteria:

  • Critically ill
  • Mentally ill or mentally disordered
  • Wards of the state
  • Prisoners
  • Refugees
  • In an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates
  • Active or suspected infection - systemic or local
  • Gustillo classification of 2 or 3
  • Bilateral tibial plateau fractures when both fracture patterns extend into the joint
  • Have an existing calcium metabolism disorder (e.g. hypercalcemia)
  • Chronic renal disease/renal failure
  • Insulin dependent diabetes
  • Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
  • Rheumatoid arthritis or other autoimmune disease.
  • Systemic disease including AIDS, HIV, hepatitis.
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
  • Subjects involved in other studies within the last month, prior to screening.
  • Pregnant or interested in becoming pregnant in the next 18 months. Females of child-bearing potential must use an acceptable method of contraception during trial participation.

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

  • 観測モデル：ケースのみ
  • 時間の展望：見込みのある

コホートと介入

グループ/コホート
介入・治療
処理
デバイス：Norian Drillable Bone Void Filler
Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
他の名前：
  • Norian Drillable

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
Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
時間枠：Day 0 (Day of surgery)
Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)
Day 0 (Day of surgery)
Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
時間枠：Day 0 (Day of surgery)
Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)
Day 0 (Day of surgery)
Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
時間枠：At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative
At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative
Ease of Use Score Measured With a Surgeon Questionnaire: Drill
時間枠：Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
時間枠：Day 0 (Date of surgery)

Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.

Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures.
Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Tap
時間枠：Day 0 (Date of surgery)

Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.

A tap is an instrument used to create threads in a hole drilled in bone.
Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
時間枠：Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
時間枠：Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
時間枠：Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
時間枠：Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
時間枠：Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
時間枠：Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Day 0 (Date of surgery)
Surgeons Overall Satisfaction With Norian Drillable
時間枠：Surgery
The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
Surgery

二次結果の測定

結果測定
メジャーの説明
時間枠
Pain and Function Assessed With the Lysholm Knee Scale
時間枠：6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee.
6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
Radiographic Parameters: Depression at Baseline
時間枠：Baseline
The anatomical grading parameter "depression" was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Baseline
Radiographic Parameters: Depression at Surgery
時間枠：Surgery
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Surgery
Radiographic Parameters: Depression at 6 Weeks
時間枠：6 week
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
6 week
Radiographic Parameters: Depression at 12 Weeks
時間枠：12 weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
12 weeks
Radiographic Parameters: Depression at 26 Weeks
時間枠：26 weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
26 weeks
Radiographic Parameters:: Depression at 52 Weeks
時間枠：52 weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
52 weeks
Radiographic Parameters: Depression at 78 Weeks
時間枠：78 weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
78 weeks
Radiographic Parameters: Condylar Widening at Baseline
時間枠：Baseline
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Baseline
Radiographic Parameters: Condylar Widening at Surgery
時間枠：Surgery
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Surgery
Radiographic Parameters: Condylar Widening at 6 Weeks
時間枠：6 weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
6 weeks
Radiographic Parameters: Condylar Widening at 12 Weeks
時間枠：12 weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
12 weeks
Radiographic Parameters: Condylar Widening at 26 Weeks
時間枠：26 weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
26 weeks
Radiographic Parameters: Condylar Widening at 52 Weeks
時間枠：52 weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
52 weeks
Radiographic Parameters: Condylar Widening at 78 Weeks
時間枠：78 weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
78 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
時間枠：Baseline
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Baseline
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
時間枠：Surgery
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Surgery
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
時間枠：6 weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
6 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
時間枠：12 weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
12 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
時間枠：26 weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
26 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
時間枠：52 weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
52 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks
時間枠：78 weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
78 weeks
Knee Function and Stability: Extension at Baseline
時間枠：Baseline
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Baseline
Knee Function and Stability: Extension at 6 Weeks
時間枠：6 weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
6 weeks
Knee Function and Stability: Extension at 12 Weeks
時間枠：12 weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
12 weeks
Knee Function and Stability: Extension at 26 Week
時間枠：26 weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
26 weeks
Knee Function and Stability: Extension at 52 Weeks
時間枠：52 weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
52 weeks
Knee Function and Stability: Extension at 78 Weeks
時間枠：78 weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
78 weeks
Knee Function and Stability: Total Range of Motion at Baseline
時間枠：Baseline
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Baseline
Knee Function and Stability: Total Range of Motion at 6 Weeks
時間枠：6 weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
6 weeks
Knee Function and Stability: Total Range of Motion at 12 Weeks
時間枠：12 weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
12 weeks
Knee Function and Stability: Total Range of Motion at 26 Weeks
時間枠：26 weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
26 weeks
Knee Function and Stability: Total Range of Motion at 52 Weeks
時間枠：52 weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
52 weeks
Knee Function and Stability: Total Range of Motion at 78 Weeks
時間枠：78 weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
78 weeks
Knee Function and Stability: Extension Stability at Baseline
時間枠：Baseline
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Baseline
Knee Function and Stability: Extension Stability at 6 Weeks
時間枠：6 weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
6 weeks
Knee Function and Stability: Extension Stability at 12 Weeks
時間枠：12 weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
12 weeks
Knee Function and Stability: Extension Stability at 26 Weeks
時間枠：26 weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
26 weeks
Knee Function and Stability: Extension Stability at 52 Weeks
時間枠：52 weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
52 weeks
Knee Function and Stability: Extension Stability at 78 Weeks
時間枠：78 weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
78 weeks

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

Synthes GmbH

協力者

Synthes Asia Pacific

捜査官

  • 主任研究者：Zsolt Balogh, MD、John Hunter Hospital, New Lambton, NSW, Australia
  • 主任研究者：Ian Harris, MD、Liverpool Hospital, Liverpool, NSW, Australia

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

2008年9月1日

一次修了 (実際)

2013年9月1日

研究の完了 (実際)

2013年9月1日

試験登録日

最初に提出

2010年2月16日

QC基準を満たした最初の提出物

2010年5月26日

最初の投稿 (見積もり)

2010年5月28日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年6月11日

QC基準を満たした最後の更新が送信されました

2015年5月26日

最終確認日

2015年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ND-AUS-01

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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