MFinity BE Pre-market Trial
Prospective Single-arm Clinical Study Assessing the Safety and Effectiveness of a Novel Femoral Stem for Total Hip Arthroplasty.
연구 개요
상세 설명
This prospective study aims to assess the clinical and radiographic outcomes of patients undergoing THA with implantation of MFinity femoral stems to determine the safety and performance of the implant in comparison with registry data for uncemented THA.
Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.
The study is conducted according to the following schedule:
- V1 : Inclusion during a preoperative visit
- V2: Surgery
- V3: Follow-up visit at 6 week post-surgery
- V4: Follow-up visit at 3 months post-surgery
- V5: Follow-up visit at 12 months post-surgery
- V6: Follow-up visit at 24 months post-surgery
The following data will be collected:
- Rate of complications, Device Deficiencies and Adverse Events
- HHS and FJS at 6 weeks, 3 months, 1 and 2 years postoperatively
- Radiologic evaluations at immediate postoperative assessment, 3 months, 1 and 2 years postoperatively
A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF).
The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Marco Vigano'
- 전화번호: +41 91 696 60 60
- 이메일: myclinicaldata@medacta.ch
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients undergoing elective primary total hip arthroplasty for primary osteoarthritis, who are suitable for implantation of a cementless femoral stem according to the MFinity femoral stem Instructions for Use
- Skeletally mature adult aged 18 years and older at the time of enrollment.
- Ability to give informed consent.
- Patient is informed of the conditions of the study and is willing to participate for the length of the prescribed follow-up period.
Exclusion Criteria:
- Not meeting the inclusion criteria.
- Active infection within the affected hip joint.
- Previous total hip replacement or hip fusion of the affected hip joint.
- Neuromuscular or neurosensory deficiency limiting the ability to evaluate the safety and effectiveness of the device.
- Bone condition that may compromise the stability of the implant
- Known allergy or hypersensitivity to the implant material
- Immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
- For women of childbearing potential*: a positive pregnancy test
- Patients with severe osteoarthritis in the contralateral hip or other joints that may interfere with the assessment of study outcomes.
Patients who have previously participated in this clinical trial.
- a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women using one of the following birth control methods are not considered of childbearing potential: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable),intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, and sexual abstinence.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Single-Arm
Patients suitable to receive Medacta Mfinity collared sted for primary THA will be invited to take part to the study during the preoperative visit.
Follow-ups are performed after 6 week, 3, 12 and 24 months.
Data collection includes clinical and radiological data for preoperative and postoperative assessments, as well as intraoperative details.
|
The MFinity Femoral Stem is intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery.
The devices are made of Ti6Al7Nb and coated in the proximal end of the shaft with TiGrowth-C titanium.
The thickness of the Ti coating is 700μm while the thickness of the HA coating is 80μm.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Implant survival rate (%) assessed by Kaplan-Meier analysis at 1 year
기간: 1 year
|
The survival rate according to a Kaplan Meier curve. The Kaplan-Meier method calculates the survival of the prosthesis by measuring the fraction of living subjects during a period after the procedure. Each time an expected event occurs (revision of the prosthesis, patients lost to follow-up, death, etc.), the probability of implant survival changes. This information is used to estimate the performance of the prosthesis. During the study, the number of stem revisions and the number of patients who died or were lost to follow-up will be collected to calculate the probability of survival. The time of occurrence will be recorded for each event. |
1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Implant survival rate (%) assessed by Kaplan-Meier analysis at 2 years
기간: 2 years
|
The survival rate according to a Kaplan Meier curve. The Kaplan-Meier method calculates the survival of the prosthesis by measuring the fraction of living subjects during a period after the procedure. Each time an expected event occurs (revision of the prosthesis, patients lost to follow-up, death, etc.), the probability of implant survival changes. This information is used to estimate the performance of the prosthesis. During the study, the number of stem revisions and the number of patients who died or were lost to follow-up will be collected to calculate the probability of survival. The time of occurrence will be recorded for each event. |
2 years
|
|
Harris Hip Score
기간: Pre-op, 6 weeks, 3 months, 1 and 2 years
|
Evaluation of the Harris Hip Score The Harris Hip Score (HHS) items include an analysis of the operated hip according to pain, function, mobility, stability and deformity analysis. The Harris Hip Score will be used to assess the patient's subjective and objective improvement in the above criteria. The usefulness of this score has been studied to estimate the clinical results after THR, it is a reference score in the field of orthopedics. The Harris hip score is scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain). |
Pre-op, 6 weeks, 3 months, 1 and 2 years
|
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Forgotten Joint Score-12 (FJS-12)
기간: Pre-op, 6 weeks, 3 months, 1 and 2 years
|
Evaluation of the Forgotten Joint Score TheForgotten Joint Score-12 (FJS-12) is a patient-reported outcome measure assessing patients' awareness of the artificial joint during activities of daily living.
The questionnaire consists of 12 items, each scored on a 5-point Likert scale (0 = never aware, 4 = mostly aware).
Raw scores are summed and linearly transformed to a 0-100 scale, with higher scores indicating less joint awareness and therefore a better outcome.
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Pre-op, 6 weeks, 3 months, 1 and 2 years
|
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Incidence of device deficiencies
기간: From surgery to 2 years post-operatively
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Number of device deficiencies reported during the study.
Device deficiencies will be documented by the investigator using the dedicated device deficiency reporting form.
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From surgery to 2 years post-operatively
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Incidence of adverse events and serious adverse events
기간: From surgery to 2 years post-operatively
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Number and percentage of adverse events (AEs) and serious adverse events (SAEs).
Events will be recorded by the investigator on the AE/SAE reporting form, classified for seriousness, severity, causality with the device and/or procedure, and outcome.
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From surgery to 2 years post-operatively
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Radiological analysis
기간: 3 months, 1 and 2 years postoperatively
|
Proportion (%) of radiographic findings (including radiolucent lines, stem subsidence, stem tilt, cup migration, endosteal cavitations, ectopic ossification, and signs of loosening, migration or osteointegration) assessed qualitatively and/or semi-quantitatively on standard anteroposterior (AP) and lateral hip radiographs, per standard of care.
Findings will be reported descriptively at each time point.
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3 months, 1 and 2 years postoperatively
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공동 작업자 및 조사자
수사관
- 수석 연구원: Frans-Jozef Vandeputte, Ziekenhuis Oost-Limburg AV, Synaps Park 1, B-3600 Genk, Belgium
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- P01.035.03
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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