Total Knee Replacement and Total Hip Replacement –

Lotus Clinical Research has extensive experience in the joint replacement model both as a CRO and as a research site. We can perform single-center joint replacement studies within our own walls, and we also utilize a network of six well-vetted sites throughout the country for multicenter investigations.

Total joint replacement (total knee and/or total hip replacement) is a good analgesic model when sponsors are seeking study results that will have a high degree of clinical relevance. Bunionectomy studies enroll more rapidly and have higher assay sensitivity than studies performed in joint replacement. However, joint replacement studies are generally well accepted by the medical community because they are considered to be clinically relevant to physicians who ultimately prescribe acute pain drugs (orthopedic surgeons, anesthesiologists, and general surgeons).

Lotus Clinical Research has implemented the following key success factors in previous joint replacement trials:

  • Selection of sites with a history of reliable enrollment
  • Consensus building among surgeons and anesthesiologists regarding an acceptable regimen of perioperative medications
  • Standardization of ancillary hospital services that tend to confound analgesic results¬†(physical therapy, continuous passive range of motion devices, early ambulation protocols, and nerve blocks)
  • Placebo response training for study subjects and research staff

Enrollment

Lotus Clinical Research is located inside of Huntington Hospital, which is a large tertiary care center with a high volume of orthopedic surgeries. As such, Lotus Clinical Research has long standing relationships with multiple orthopedic surgeons and anesthesiologists within the hospital. This facilitates rapid enrollment into joint replacement studies.