A study to assess success after knee surgery
- Conditions
- Health Condition 1: M999- Biomechanical lesion, unspecified
- Registration Number
- CTRI/2023/04/051751
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Male/ female participants between =18 years and = 45 years of age at the time of consent
2. Participants with traumatic ACL tears with or without associated meniscus injuries requiring primary ACL reconstruction surgery
3. Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures
1. Participants with lateral/medial collateral ligament injury or posterior cruciate ligament injury
2. Participants with BMI =35 kg/m2
3. Participants who had undergone previous surgery in the same or contralateral knee
4. Participants with HbA1c ? 9% (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C)
5. Participants who are smokers (smoking ?20 cigarettes/day)
6. Participants with sensitivity to PEEK material
7. Participants with a history of deep vein thrombosis (DVT)
8. Participants with arthritis of same or contralateral knee
9. Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this clinical investigation plan
10. Pregnant and lactating female at the time of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess functional outcomes of Knee in each cohort of Peek button-open and Peek button-closed.Timepoint: Screening, month 3, month 6, month 12, month 18 and month 24
- Secondary Outcome Measures
Name Time Method