RTI: Real-Time Instrument for Acetabular Shell Positioning

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02006251
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Device: Real-time Instrumentation; Procedure: Standard Total Hip Arthroplasty

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Acetabular Shell Position Using Real-Time Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Total Hip Arthroplasty Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty.	Procedure: Standard Total Hip Arthroplasty; Total hip arthroplasty performed according to standard of care
Experimental: Real-time Instrumentation Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty	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.; Other Names: RTI ; Procedure: Standard Total Hip Arthroplasty; Total hip arthroplasty performed according to standard of care

Outcome Measures

Primary Outcome Measures

1. Difference Between Planned and Actual Values of Abduction [Through 2 weeks after surgery.]

   The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.

Secondary Outcome Measures

1. Difference Between Planned and Actual Values of Version [Through 2 weeks after surgery]

   The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.

2. Difference in the Time for Acetabular Preparation and Shell Placement Between the Two Groups [Intraoperatively (during surgery)]

   These data were not collected

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Wael Barsoum, Vice-chairman, Department of Orthopaedic Surgery, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02006251
• Other Study ID Numbers: CCF 13-940
• First Posted: Dec 10, 2013
• Last Update Posted: Jul 1, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Wael Barsoum, Vice-chairman, Department of Orthopaedic Surgery, The Cleveland Clinic: Total Hip Arthroplasty; Acetabular positioning; Patient specific instrumentation; Preoperative planning

Study Results

Participant Flow

Arm/Group Title	Standard Total Hip Arthroplasty	Real-time Instrumentation
Arm/Group Description	Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care	Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty 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. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care
Period Title: Overall Study
STARTED	12	12
COMPLETED	10	11
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Standard Total Hip Arthroplasty	Real-time Instrumentation	Total
Arm/Group Description	Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care	Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty 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. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care	Total of all reporting groups
Overall Participants	10	11	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.0 (15.0)	59.3 (11.8)	60.1 (13.1)
Sex: Female, Male (Count of Participants)
Female	5 50%	6 54.5%	11 52.4%
Male	5 50%	5 45.5%	10 47.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Difference Between Planned and Actual Values of Abduction
Description	The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.
Time Frame	Through 2 weeks after surgery.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Total Hip Arthroplasty	Real-time Instrumentation
Arm/Group Description	Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care	Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty 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. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care
Measure Participants	10	11
Mean (Standard Deviation) [degrees]	5.6 (13.0)	7.5 (9.4)

2. Secondary Outcome

Title	Difference Between Planned and Actual Values of Version
Description	The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.
Time Frame	Through 2 weeks after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Total Hip Arthroplasty	Real-time Instrumentation
Arm/Group Description	Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care	Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty 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. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care
Measure Participants	10	11
Mean (Standard Deviation) [degrees]	4.1 (7.8)	0.6 (9.6)

3. Secondary Outcome

Title	Difference in the Time for Acetabular Preparation and Shell Placement Between the Two Groups
Description	These data were not collected
Time Frame	Intraoperatively (during surgery)

Outcome Measure Data

Analysis Population Description

These data were not collected

Arm/Group Title	Standard Total Hip Arthroplasty	Real-time Instrumentation
Arm/Group Description	Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care	Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty 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. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care
Measure Participants	0	0

Adverse Events

Arm/Group Title	Standard Total Hip Arthroplasty		Real-time Instrumentation
Arm/Group Description	Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care		Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty 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. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care
All Cause Mortality
	Standard Total Hip Arthroplasty		Real-time Instrumentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Total Hip Arthroplasty		Real-time Instrumentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		1/11 (9.1%)
Musculoskeletal and connective tissue disorders
Fall followed by dislocation	0/10 (0%)	0	1/11 (9.1%)	1
Other (Not Including Serious) Adverse Events
	Standard Total Hip Arthroplasty		Real-time Instrumentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.