Evaluating the ORIGIN® CR knee prosthesis after total knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and performance of the ORIGIN® CR devices used in total knee replacement surgeries. It will involve 199 patients who will be monitored for one year post-surgery to evaluate the revision rate and improvements in knee function using the Knee Society Score. The study hypothesizes that patients will experience significant improvements in the feel and function of the prosthesis within the first year, with continued benefits observed at the two-year mark. Participants will be followed for a total of 24 months to gather comprehensive data on outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female over 18 years of age
* Each patient who is willing to give informed consent.
* Clinically indicated for a total knee replacement
* Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age
* Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.

Exclusion Criteria:

* Acute or chronic, local or systemic infection
* Muscular, ligamental, neurological, psychological or vascular deficits
* Bone destruction or poor bone quality likely to affect implant stability (requiring a femoral and/or a tibial stem and/or a thick insert)
* Any concomitant condition likely to affect implant integration or function
* Allergy or hypersensitivity to any of the materials used
* For devices in CoCrMo (ISO 5832/4): renal and hepatic impairment
* Hip Knee Ankle (HKA) angle \< 165° or \> 195°
* Severe collateral ligaments deficiency (requiring a more constrained prosthesis)
* Posterior cruciate ligament deficiency
* Major anatomical deformities
* Severe flexion contracture or severe recurvatum
* Revision of a partial or total knee prosthesis
* Non-extractible material (e.g. screws, plate, intramedullary nail, osteosynthesis material…) which can create a conflict with any component of the prosthesis
* Distal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thickness
* Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert)
* Bone degradation requiring an anchoring stem for femoral component

Where it's running

• GZA Ziekenhuizen - campus Sint-Augustinus
  Antwerp, Belgium Recruiting
• AZ Voorkempen
  Malle, Belgium Recruiting

Study contacts

• Study coordinator: Bojana Gannevat
• Email: bojana.gannevat@symbios.ch
• Phone: +41 4242626

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Suzetrigine for pain relief after knee replacement

  This trial tests whether suzetrigine can reduce opioid use after a total knee replacement compared with placebo.

  Recruiting Phase 3 Hospital for Special Surgery, New York · New York, New York · NCT07864896

• Femoral Component Alignment in Total Knee Replacement: Extramedullary vs Intramedullary Guidance

  This study tests whether an external (extramedullary) guide for placing the femoral component in knee replacement works as well as the traditional internal (intramedullary) guide.

  Recruiting I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Milan and 2 other locations · NCT07815080

• Physical therapy to improve gait and foot pressure after total knee replacement.

  This program will see if a structured physical therapy rehabilitation program helps women who had a unilateral total knee replacement (ages 40–70) walk more normally and balance weight better on their feet.

  Recruiting Jouf University · Sakakah · NCT07556003

• Dressing experiences and self-care after hip or knee replacement

  This observational study tests how patients manage dressings and wound care after hip or knee replacement within an ERAS pathway, to see how comfortable the dressings are and what education patients find helpful.

  Recruiting Bournemouth University · Bournemouth, Dorset and 1 other locations · NCT07471243

• Binaural beats to reduce pain and anxiety after hip or knee replacement

  This will try a 30-minute binaural beats audio session in the PACU to see if it lowers pain and anxiety for adults having same-day total hip or knee replacement.

  Recruiting University of Miami · Miami, Florida · NCT07437469

• Spinal versus general anesthesia for recovery after total knee replacement

  This will test whether spinal anesthesia or general anesthesia leads to better early postoperative recovery for adults who have had total knee replacement.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07275983

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.