Health Condition 1: O- Medical and Surgical
Conditions
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/female participants aged =18 to =60 years at the time of surgery 2. Participants who had undergone arthroscopic ACL reconstruction procedure using adjustable PEEK Button at least one month prior to their follow-up 3. Participants who are willing to provide written informed consent (in case of physical visit to the site) or verbal informed consent (in case of telephonic visit)
Exclusion criteria
Exclusion criteria: 1.Participants who have suffered traumatic injury to the operated knee post ACL reconstruction procedure 2. Participants who are not willing to attend the follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the functional outcomes after ACL reconstruction procedure using a) International Knee Documentation Committee score (IKDC) b) Modified Cincinnati Rating System QuestionnaireTimepoint: Duration between one month prior to their follow-up date and date of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the patient reported outcomes and activity levels (pre and post) after ACL Reconstruction Procedure using: a) Single Assessment Numeric Evaluation (SANE) b) Tegner activity scale 2. To evaluate the quality of life post ACL reconstruction procedure using Quality of Life subscale of Knee Injury and Osteoarthritis Outcome Score(KOOS) score 3. To evaluate the safety of the implants by evaluating ACL reconstruction failure rate, device and surgery related adverse events.Timepoint: Duration between one month prior to their follow-up date and date of surgery | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Limited
Outcome results
None listed