Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique (RCRPRFM)
11 lipca 2017 zaktualizowane przez: HealthPartners Institute
Arthroscopic Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique: A Randomized Blinded Outcomes Study
This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques.
One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other technique is the standard double row repairs utilizing medial and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM).
It is hypothesized that patients undergoing the surgery with the PRFM will report a higher quality of life than the patients that do not receive this treatment.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
97
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Minnesota
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Bloomington, Minnesota, Stany Zjednoczone, 55431
- TRIA Orthopaedic Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Evidence of a rotator cuff tear as determined by clinical examination and diagnostic imaging (MRI)
- Patient undergoes arthroscopic rotator cuff repair
- Age 18 or older
Exclusion Criteria:
Pre-operative exclusion criteria
- Patient has had a previous arthroscopic rotator cut repair
- A previous diagnosis of Rheumatoid Arthritis
- Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder,
- Evidence of significant rotator cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
- Medical device that would exclude the patient from having a MRI, including a pacemaker, cardiac defibrillator, aneurysm clips, carotid artery clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, or ear implant.
- Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
- Inability to speak or read English
- Psychiatric illness that precludes informed consent.
- Pregnant patients.
- Age 17 or younger
- Unwillingness to be followed for 2 years.
- Bilateral Rotator cuff tear confirmed by clinical exam and MRI
- Patients enrolled in the study who demonstrate retear on clinical exam and MRI, then elect for a repeat surgery.
Intra-operative exclusion criteria (Note: This information will be collected during the chart audit and patients will be excluded from the study at that time.)
- Irreparable cuff tears or tears extending into the subscapularis or teres minor
- Isolated teres minor or subscapularis tears.
- Inelastic and immobile tendon which cannot be advanced to articular margin
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Double Row
|
|
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Eksperymentalny: Double Row with PRFM
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Return to Function
Ramy czasowe: Baseline
|
The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score.
There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module.
More patients completed a baseline measure than those that completed the entire study.
|
Baseline
|
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Return to Function
Ramy czasowe: 6 months
|
The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score.
There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module.
More patients completed a baseline measure than those that completed the entire study.
|
6 months
|
|
Return to Function
Ramy czasowe: 24 months
|
Western Ontario Rotator Cuff Index
|
24 months
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Spraspinatus Strength Measurements
Ramy czasowe: Baseline
|
Strength of supraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
Baseline
|
|
MRI
Ramy czasowe: 6 months
|
MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear. Higher grades are worse radiographic outcomes. |
6 months
|
|
Supraspinatus Strength Measurements
Ramy czasowe: 6 months
|
Strength of supraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
6 months
|
|
Supraspinatus Strength Measurements
Ramy czasowe: 24 months
|
Strength of supraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
24 months
|
|
Infraspinatus Strength Measurements
Ramy czasowe: Baseline
|
Strength of infraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
Baseline
|
|
Infraspinatus Strength Measurements
Ramy czasowe: 6 months
|
Strength of infraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
6 months
|
|
Infraspinatus Strength Measurements
Ramy czasowe: 24 months
|
Strength of infraspinatus in newton meters with a hand held dynomometer.
Three trials were recorded and an average taken.
Data is reported as measured by % of uninvolved.
Average of strength measures for involved/average of strength measures for uninvolved x 100.
|
24 months
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 lipca 2011
Zakończenie podstawowe (Rzeczywisty)
1 grudnia 2015
Ukończenie studiów (Rzeczywisty)
1 grudnia 2015
Daty rejestracji na studia
Pierwszy przesłany
4 sierpnia 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 października 2014
Pierwszy wysłany (Oszacować)
6 października 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
9 sierpnia 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 lipca 2017
Ostatnia weryfikacja
1 października 2015
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 04100-11-C
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