SINFIX-2022 パイロット段階
市販前臨床調査 Inovedis SINEFIX
Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full-thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended.
Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs.
For RCTs, treatment options include both surgical and non-surgical (conservative) procedures.
In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
-
Tübingen、ドイツ、72074
- Orthopädisch Chirurgisches Centrum (OCC)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patient indicated for surgical repair of the rotator cuff tear according to current guidelines
- Patient aged 18 years or older
- Up to 2 cm tear size of supraspinatus, infraspinatus (medio-lateral)
- Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior)
Exclusion Criteria:
- Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder
- History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments
- Inflammatory arthropathies
- Subject with a contraindication/non-compliance for MRI examination
- Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule
- Pregnant and breastfeeding woman
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：SINEFIX
Rotator cuff repair with the SINEFIX implant, using the SINEFIX instruments |
Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments |
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 |
|---|---|---|
|
Healing integrity
時間枠：3 months post operation
|
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no) |
3 months post operation
|
|
Re-tear rate
時間枠：3 months post operation
|
Re-tear rate will be assessed with MRI |
3 months post operation
|
|
Dislocation of the implant
時間枠：3 months post operation
|
Presence of dislocation of the implant will be assessed with MRI (yes/no) |
3 months post operation
|
|
Bursitis
時間枠：3 months post operation
|
Presence of bursitis will be assessed with MRI (yes/no) |
3 months post operation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Surgery time
時間枠：Immediately post procedure
|
The total procedure duration will be recorded as the surgery time |
Immediately post procedure
|
|
Usability and workflow assessment
時間枠：Immediately post procedure
|
Usability and workflow assessment will be evaluated after each intervention through a practitioner's questionnaire covering different aspects of the implant and instruments |
Immediately post procedure
|
|
Functional and clinical outcome after rotator cuff repair
時間枠：At 6 months, 1 and 2 years follow-up
|
Functional and clinical outcome after rotator cuff repair will be assessed using the total Constant Murley score, which ranges from 0 (worst outcome) to 100 (best outcome) |
At 6 months, 1 and 2 years follow-up
|
|
Functional and clinical outcome after rotator cuff repair as compared with baseline
時間枠：At 6 months, 1 and 2 years follow-up
|
Functional and clinical outcome after rotator cuff repair will be assessed using the change of the total Constant Murley score (range 0-100) as compared to baseline |
At 6 months, 1 and 2 years follow-up
|
|
Shoulder function after rotator cuff repair (subjective evaluation)
時間枠：At 10 weeks, 6, 12, and 24 months
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Shoulder function after rotator cuff repair (subjective evaluation) will be assessed through the Subjective Shoulder Value (SSV) which ranges from 0% to 100% (best outcome) |
At 10 weeks, 6, 12, and 24 months
|
|
Shoulder function after rotator cuff repair (physical examination-active external rotation)
時間枠：At 10 weeks, 6, 12, and 24 months
|
Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active external rotation (range 0°-90°) |
At 10 weeks, 6, 12, and 24 months
|
|
Shoulder function after rotator cuff repair (physical examination-active anteversion)
時間枠：At 10 weeks, 6, 12, and 24 months
|
Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active anteversion (0°-180°) |
At 10 weeks, 6, 12, and 24 months
|
|
Healing integrity
時間枠：At 6, 12, and 24 months
|
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no) |
At 6, 12, and 24 months
|
|
Re-tear rate
時間枠：At 6, 12, and 24 months
|
Re-tear rate will be assessed with MRI |
At 6, 12, and 24 months
|
|
Dislocation of the implant
時間枠：At 6, 12, and 24 months
|
Presence of dislocation will be assessed with MRI (yes/no) |
At 6, 12, and 24 months
|
|
Bursitis
時間枠：At 6, 12, and 24 months
|
Presence of bursitis will be assessed with MRI (yes/no) |
At 6, 12, and 24 months
|
|
Complications
時間枠：During the follow up time (up to 24 months)
|
Complications will be systematically reported. Complications of particular interest for the purpose of the study are neurological problems, bleeding, impaired wound healing, infection and frozen shoulder. |
During the follow up time (up to 24 months)
|
|
Patient satisfaction
時間枠：At 10 weeks, 6, 12, 24 months
|
The patient will be asked to rate his/her satisfaction with outcome of the surgical repair (0=completely unsatisfied, 1=unsatisfied, 2=satisfied, 3=completely satisfied) |
At 10 weeks, 6, 12, 24 months
|
|
Safety endpoint
時間枠：During the intervention and the follow up time (up to 24 months)
|
Safety of the device will be evaluated by systematically reporting device deficiencies (DDs), adverse events (AEs) and serious adverse events (SAEs) and by monitoring the frequency and incidence of these events |
During the intervention and the follow up time (up to 24 months)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SINEFIX-2022
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?
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