Trial Outcomes & Findings for Real-Time Instrument for Acetabular Shell Positioning (NCT NCT02006251)

Results Overview

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

Recruitment status

TERMINATED

Target enrollment

24 participants

Primary outcome timeframe

Through 2 weeks after surgery.

Results posted on

2023-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	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. Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care	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 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
Overall Study STARTED	12	12
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Total Hip Arthroplasty n=10 Participants 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	Real-time Instrumentation n=11 Participants 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 n=21 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 15.0 • n=10 Participants	59.3 years STANDARD_DEVIATION 11.8 • n=11 Participants	60.1 years STANDARD_DEVIATION 13.1 • n=21 Participants
Sex: Female, Male Female	5 Participants n=10 Participants	6 Participants n=11 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=10 Participants	5 Participants n=11 Participants	10 Participants n=21 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Through 2 weeks after surgery.

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

Outcome measures

Outcome measures
Measure	Standard Total Hip Arthroplasty n=10 Participants 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	Real-time Instrumentation n=11 Participants 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
Difference Between Planned and Actual Values of Abduction	5.6 degrees Standard Deviation 13.0	7.5 degrees Standard Deviation 9.4

SECONDARY outcome

Timeframe: Through 2 weeks after surgery

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

Outcome measures

Outcome measures
Measure	Standard Total Hip Arthroplasty n=10 Participants 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	Real-time Instrumentation n=11 Participants 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
Difference Between Planned and Actual Values of Version	4.1 degrees Standard Deviation 7.8	0.6 degrees Standard Deviation 9.6

SECONDARY outcome

Timeframe: Intraoperatively (during surgery)

Population: These data were not collected

Difference in the time for acetabular preparation and shell placement between the two groups were not collected

Outcome measures

Outcome data not reported

Adverse Events

Standard Total Hip Arthroplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Real-time Instrumentation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Total Hip Arthroplasty n=10 participants at risk 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	Real-time Instrumentation n=11 participants at risk 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
Musculoskeletal and connective tissue disorders Fall followed by dislocation	0.00% 0/10	9.1% 1/11 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Wael Barsoum

Cleveland Clinic

Phone: 2164444954

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place