Clinical Trials Logo

Clinical Trial Summary

The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by video camera, in order to time the length of surgery and each surgical step. The number of surgical trays required for each case will be recorded. As an additional endpoint, the investigators will measure limb and component alignment on x-rays to determine if these two methods achieve equivalent alignment results. The thickness of bone cuts will be compared to the surgical plan and to each other.

The primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.


Clinical Trial Description

Patient-specific instrumentation (PSI) has been developed for total knee arthroplasty (TKA) with several potential advantages over traditional instrumentation (TI). Shortened surgical time, fewer surgical instruments, and improved alignment are some of these proposed advantages. We sought to examine these assertions.

52 patients (26 per group) were enrolled in a prospective, randomized trial comparing CT-based PSI with TI. No difference was seen in average patient age (68 years) or BMI (31) between groups (p=0.84 and p=0.89), although there were more males in the PSI group (14 vs 7, p=0.002). A single surgeon and consistent staff performed the surgeries with the same knee prostheses, and all cases were videotaped to measure the length of surgery and each individual step. Any additional bone cuts, size changes, or ligament releases made to achieve correct alignment and balance were documented. The number of instrument trays opened for each case was recorded. Postoperative long alignment and lateral radiographs were taken to measure the coronal and sagittal plane component alignment and mechanical axis in each patient. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01124305
Study type Interventional
Source Anderson Orthopaedic Research Institute
Contact
Status Completed
Phase Phase 4
Start date May 2010
Completion date November 2012

See also
  Status Clinical Trial Phase
Completed NCT05464862 - The Effect of PPB Using 10, 20 and 30 ml of Lidocaine, Study on Volunteers Phase 4
Completed NCT05346822 - The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty N/A
Completed NCT05420194 - Assessment of Postural Stability in Patients With Total Knee Arthroplasty
Active, not recruiting NCT03211663 - Performance of MOTO Medial® Unicompartmental Knee Arthroplasty
Recruiting NCT04952220 - Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee
Completed NCT01560767 - Perioperative Analgesia for Knee Arthroplasty (PAKA) Phase 4
Recruiting NCT05566561 - Para-sartorial Compartment Block in Knee Surgery N/A
Recruiting NCT05859269 - Methylprednisolone Taper, Lower Extremity Phase 4
Completed NCT03071250 - An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty
Completed NCT03302832 - Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty N/A
Terminated NCT04620525 - Cognition, Pain and Wellbeing
Completed NCT05621161 - ESPB vs FICB for Pain Management Following Total Hip Prosthesis Surgery N/A
Completed NCT01242085 - Preoperative Alignment of Total Knee Replacement Phase 3
Withdrawn NCT00589485 - Total Knee Replacement Using Simplex® or Cobaltâ„¢ Bone Cement N/A
Recruiting NCT04163445 - Comparison of TKAs Using Force Plate Analysis N/A
Completed NCT05975879 - A Study of the Feasibility of Using the Dietary Supplement "ARTNEO" in Patients With Osteoathritis N/A
Not yet recruiting NCT06284824 - Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems N/A
Completed NCT00862316 - Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit N/A
Completed NCT04496856 - Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients N/A
Completed NCT03421249 - Treatment of Knee Osteoarthrosis Using the Electromagnetic Fields N/A