어깨 및 고관절의 MICRORAPTOR™ 봉합 앵커의 안전성 및 성능
어깨 및 고관절 관절경적 불안정성 복구에서 MICRORAPTOR REGENESORB, 결절이 없는 REGENESORB 및 결절이 없는 PEEK 봉합 앵커(및 MINITAPE 봉합)의 안전성과 성능을 평가하기 위한 전향적 다기관 시판 후 임상 후속 연구
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado
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Colorado Springs, Colorado, 미국, 80920
- Colorado Springs Orthopaedic Group
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Florida
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Oakland Park, Florida, 미국, 33334
- Holy Cross Orthopedic Institute
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Georgia
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Brookhaven, Georgia, 미국, 30329
- Emory University - Brookhaven
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Maryland
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Annapolis, Maryland, 미국, 21401
- Luminis Health Research Institute
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Ohio
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Columbus, Ohio, 미국, 43202
- Ohio State University Wexner Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73114
- Oklahoma Sports and Science Orthopedics / The Physician's Group
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South Carolina
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Columbia, South Carolina, 미국, 29203
- Palmetto/Prisma Health - University of South Carolina Orthopaedics
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Greenville, South Carolina, 미국, 29615
- Steadman Hawkins Clinic of the Carolinas
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Virginia
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Virginia Beach, Virginia, 미국, 23452
- Atlantic Orthopaedic Specialists
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Woodbridge, Virginia, 미국, 22191
- Center for Advanced Orthopaedics / Nova Orthopedic & Spine Care
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Wisconsin
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Ashland, Wisconsin, 미국, 54806
- Memorial Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
피험자는 다음 적응증에 대해 연조직을 뼈에 재부착해야 합니다.
- 어깨 - Bankart 수리를 위한 관절낭 안정화, 전방 어깨 불안정성, SLAP 병변 수리, 관절낭 이동 또는 관절낭 관절 재건, 이두근 건고정술, 회전근 개 수술(무매듭 앵커만 해당)
- 엉덩이 - 비구순 수리/재건
설명
포함 기준:
피험자는 다음 적응증에 대해 연조직을 뼈에 재부착해야 합니다.
- 어깨 - Bankart 수리를 위한 관절낭 안정화, 전방 어깨 불안정성, SLAP 병변 수리, 관절낭 이동 또는 관절낭 관절 재건, 이두근 건고정술, 회전근 개 수술(무매듭 앵커만 해당)
- 엉덩이 - 비구순 수리/재건
- 피험자는 EC 승인 정보에 입각한 동의서에 서명하여 연구 참여에 동의했습니다.
- 피험자는 수술 당시 ≥18세입니다.
- 필요한 모든 연구 방문을 할 의향과 능력.
- 지침을 따를 수 있습니다.
제외 기준:
- 임플란트 재료에 대해 알려진 과민증. 재료 민감도가 의심되는 경우 이식 전에 적절한 테스트를 수행하고 민감도를 배제해야 합니다.
- 낭포성 변화 또는 심각한 골감소증과 같은 뼈의 병리학적 상태는 안전한 앵커 고정을 손상시킬 수 있습니다.
- 부착할 연조직의 병리학적 상태는 봉합사에 의한 안전한 고정을 손상시킬 수 있습니다.
- 안전한 앵커 고정을 손상시키는 분쇄된 뼈 표면.
- 적절한 고정 지지대를 제거하거나 제거하는 경향이 있거나 치유를 지연시키는 물리적 상태.
- 감염의 존재.
- 치료 기간 동안 활동을 제한하거나 지시를 따르려는 피험자의 능력이나 의지를 제한하는 상태.
- 현재 담배 제품(궐련, 무연 담배, 전자담배, 베이핑 등)을 사용하고 있습니다.
- 동시 양측 수술.
- 이전 MICRORAPTOR REGENESORB, MICRORAPTOR Knotless REGENESORB 또는 MICRORAPTOR Knotless PEEK 이식.
- 방문 1로부터 30일 이내 또는 연구 동안 다른 임상 시험의 치료 기간에 참여.
- 임신 중이거나 수유 중인 여성.
- 치료에 대한 순응도가 낮은 이력.
- 관절 공간에서 수행된 이전 동측 수술.
- 연구자의 의견에 따라 피험자가 안전하게 연구에 참여하는 것을 방해하는 의학적 또는 신체 상태가 있는 피험자.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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MICRORAPTOR™ REGENESORB™ 봉합 앵커
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Smith & Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor는 연조직을 뼈에 단단히 부착하기 위한 고정 장치입니다.
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MICRORAPTOR™ Knotless REGENESORB™ 봉합 앵커
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MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor는 삽입기의 앵커와 봉합사 스레더로 구성된 고정 장치입니다.
앵커는 근위 앵커 본체(REGENESORB™) 및 비흡수성 PEEK(폴리에테르 에테르 케톤) 원위 앵커 팁의 구성 요소로 구성됩니다.
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MICRORAPTOR™ 무매듭 PEEK 봉합 앵커
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MICRORAPTOR™ Knotless PEEK Suture Anchor는 삽입기의 앵커와 봉합사 스레더로 구성된 클래스 IIb 장치입니다.
앵커는 근위 앵커 본체(PEEK)와 비흡수성 PEEK 원위 앵커 팁으로 구성됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Repair Failure Rate at 6 Months
기간: 6 months
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Repair failure at 6 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 6-month follow-up.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Repair Failure Rate at 12 Months
기간: 12 months
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Repair failure at 12 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 12-month follow-up.
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12 months
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Visual Analogue Scale (VAS) Pain Change From Baseline
기간: Baseline to 6 months, 12 months, and 24 months
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Pain was assessed using a Visual Analogue Scale (VAS) where participants indicated their pain level by marking a point that represented their perceived pain intensity.
Scores ranged from 0 to 100, with 0 representing no pain and 100 representing the worst imaginable pain (i.e., a worse outcome).
A decrease in VAS Pain score indicated a reduction in pain (i.e., a better outcome) and an increase indicated worsening in pain (i.e., a worse outcome).
The mean change in pain score was recorded on the VAS from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
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Baseline to 6 months, 12 months, and 24 months
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Repair Failure Rate at 24 Months (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY)
기간: 24 months
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Repair failure at 24 months was collected only for participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor.
Repair failure was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 24-month follow-up.
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24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Acetabular Labral Condition
기간: Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on acetabular labral condition classification. The number of participants acetabular labral condition was classified as one of the following:
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Baseline, 6 months, and 24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Joint Effusion
기간: Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on joint effusion classification. The number of participants joint effusion was classified as one of the following:
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Baseline, 6 months, and 24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Bone Marrow Edema
기간: Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on the presence of bone marrow edema.
The number of participants with bone marrow edema were categorized as 'Absent' or 'Present'.
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Baseline, 6 months, and 24 months
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Rowe Shoulder Score Change From Baseline (Shoulder Participants ONLY)
기간: Baseline to 6 months, 12 months, and 24 months
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The Rowe shoulder score for shoulder instability evaluated using a 3-item instrument completed by the investigator or qualified, delegated study staff. Its questions addressed the categories of shoulder stability (0 to 50 points), motion (0 to 20 points), and function (0 to 30 points). Scores ranged from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and =< 50 points indicating a poor evaluation. An increase in Rowe score indicated reduced shoulder instability (i.e., a better outcome) and a decrease indicated worsening instability (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Western Ontario Shoulder Instability Index (WOSI) Score Change From Baseline (Shoulder Participants ONLY)
기간: Baseline to 6 months, 12 months, and 24 months
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Western Ontario Shoulder Instability Index (WOSI) was a participant completed instrument. Its categories included "physical symptoms", "sports, recreation, work", "pain", "lifestyle", and "emotion", with questions within each category scored from 0 to 100 using a visual analog scale. Scores were combined to produce an overall score that ranged from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function. A decrease in WOSI score indicated improving shoulder function (i.e., a better outcome) and an increase indicated worsening shoulder function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Constant-Murley Shoulder Scale Change From Baseline (Should Participants ONLY)
기간: Baseline to 6 months, 12 months, and 24 months
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Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology: pain, activities of daily living (ADL), range of motion (ROM), and strength. The total score ranged from 0 to 100, with a higher score indicating better shoulder function. An increase in CMS score indicated improving shoulder function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Hip Outcome Score Activities of Daily Living (HOS-ADL) Score Change in Baseline (Hip Participants ONLY)
기간: Baseline to 6 months, 12 months, and 24 months
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The Hip Outcome Score Activities of Daily Living (HOS-ADL) subscale consisted of 17 items that addressed specific activities related to hip function. Scores ranged from 0 to 100 with 0 representing the least function and 100 representing the most function. An increase in HOS-ADL score indicated improved hip function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Modified Harris Hip Score (mHHS) Change From Baseline (Hip Participants ONLY)
기간: Baseline to 6 months, 12 months, and 24 months
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Modified Harris Hip Score (mHHS) is a joint specific score covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores ranged from 0 to 100, with 0 representing worse disability and 100 representing less disability. An increase in mHHS indicated improved hip joint function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Mary Ozokwere, Smith & Nephew, Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .