Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02006251
Other study ID # CCF 13-940
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 2013
Est. completion date May 2014

Study information

Verified date January 2023
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty. The investigators will enroll 44 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of real-time instrument from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments. The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.


Recruitment information / eligibility

Status Terminated
Enrollment 24
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria: - Primary, unilateral anterior or posterior total hip arthroplasty - 18 to 85 years old at time of surgery - Able to get a pre- and post-operative CT scan at the Cleveland Clinic Exclusion Criteria: - Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator. - Pregnancy - Incarceration - Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Real-time Instrumentation
To prepare the acetabulum and place the implants on the day of surgery, surgeons will receive either parts necessary to create the real-time with a surrogate model of the acetabular surface or standard surgical alignment instruments provided by the manufacturer of the implant. For the experimental group, the surgeon will be provided with 3 parts necessary to create the real-time instrument: (1) a patient-specific surrogate bone model with a built-in guide pin trajectory which was planned in the 3D planning software, (2) a non-specific plastic arm available in different sizes, and (3) bone cement. The real-time instrument is created to position a peripheral guide wire on the acetabular rim to serve as a visual aid for reaming and impacting the acetabular shell using standard reaming tools supplied by the manufacturer. Once the acetabular shell is placed, the procedure is performed in the same manner for both groups, using the standard manufacturer instruments.
Procedure:
Standard Total Hip Arthroplasty
Total hip arthroplasty performed according to standard of care

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Small T, Krebs V, Molloy R, Bryan J, Klika AK, Barsoum WK. Comparison of acetabular shell position using patient specific instruments vs. standard surgical instruments: a randomized clinical trial. J Arthroplasty. 2014 May;29(5):1030-7. doi: 10.1016/j.arth.2013.10.006. Epub 2013 Oct 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Difference Between Planned and Actual Values of Abduction The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared. Through 2 weeks after surgery.
Secondary Difference Between Planned and Actual Values of Version The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared. Through 2 weeks after surgery
Secondary Difference in the Time for Acetabular Preparation and Shell Placement Between the Two Groups Difference in the time for acetabular preparation and shell placement between the two groups were not collected Intraoperatively (during surgery)
See also
  Status Clinical Trial Phase
Terminated NCT02818894 - Spinal Anesthesia in Total Hip Arthroplasty Phase 4
Completed NCT02242201 - Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular Phase 4
Completed NCT02414542 - Minima Clinical Study
Completed NCT01817010 - Strength and Function Following Total Hip Arthroplasty N/A
Completed NCT01443975 - Clinical Evaluation on the Use of the X-pander Device N/A
Recruiting NCT05530174 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture N/A
Recruiting NCT05530551 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA N/A
Recruiting NCT05054192 - Reliability and Validity of Modified Four Square Step Test
Recruiting NCT06141928 - Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty N/A
Recruiting NCT04492462 - The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery N/A
Withdrawn NCT02926651 - Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty Phase 4
Completed NCT02308813 - Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip N/A
Recruiting NCT02032017 - Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation. N/A
Recruiting NCT01312077 - The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement Phase 4
Withdrawn NCT01380665 - Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty Phase 4
Recruiting NCT05893563 - Corail Stability at 5-Years Post-Total Hip Arthroplasty
Recruiting NCT06088069 - Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty N/A
Active, not recruiting NCT03210844 - The Clinical Outcomes After Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty N/A
Recruiting NCT04801680 - Mpact 3D Metal Cup PMS
Completed NCT01525667 - Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty Phase 1/Phase 2