Trial Outcomes & Findings for The Viability of Short Stems in Total Hip Arthroplasty (NCT NCT02577822)

Last Updated: 2020-01-09

Results Overview

Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Mental Composite Score (MCS) range from 5.2 to 76.3 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Assesed pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

Results posted on

2020-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Short Stem Group Short femoral stem Taperloc short length stem	Long Stem Group standard-length stem Taperloc standard length stem
Overall Study STARTED	27	33
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	6	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Viability of Short Stems in Total Hip Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Short Stem Group n=27 Participants Short femoral stem Taperloc short length stem	Long Stem Group n=33 Participants standard-length stem Taperloc standard length stem	Total n=60 Participants Total of all reporting groups
Age, Continuous	61.28 years STANDARD_DEVIATION 10.73 • n=5 Participants	58.70 years STANDARD_DEVIATION 11.99 • n=7 Participants	60.47 years STANDARD_DEVIATION 11.76 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	33 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Assesed pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

Population: Discrepancies between the total number of patients analyzed and patients included in participant flow is due to patients lost to follow-up during the course of the study despite attempts to contact them by the research team

Outcome measures

Outcome measures
Measure	Short Stem Group n=27 Participants Short femoral stem Taperloc short length stem	Long Stem Group n=33 Participants standard-length stem Taperloc standard length stem
Mean VR-12 Mental Composite Score Through 2 Years Post Operative VR-12 MCS Mean Score (Pre-Op)	47.3 T-Score Standard Deviation 11.3	50.6 T-Score Standard Deviation 13.8
Mean VR-12 Mental Composite Score Through 2 Years Post Operative VR-12 MCS Mean Score (6 wk)	54.9 T-Score Standard Deviation 8.9	53.8 T-Score Standard Deviation 11.7
Mean VR-12 Mental Composite Score Through 2 Years Post Operative VR-12 MCS Mean Score (3 mo)	56.4 T-Score Standard Deviation 11.2	56.9 T-Score Standard Deviation 10.6
Mean VR-12 Mental Composite Score Through 2 Years Post Operative VR-12 MCS Mean Score (6 mo)	54.8 T-Score Standard Deviation 10.2	56.4 T-Score Standard Deviation 9.3
Mean VR-12 Mental Composite Score Through 2 Years Post Operative VR-12 MCS Mean Score (1 yr)	53.0 T-Score Standard Deviation 9.6	56.7 T-Score Standard Deviation 8.3
Mean VR-12 Mental Composite Score Through 2 Years Post Operative VR-12 MCS Mean Score (2 yr)	52.3 T-Score Standard Deviation 9.9	55.3 T-Score Standard Deviation 9.9

PRIMARY outcome

Timeframe: Assessed pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Physical Composite Score (PCS) range from 6.3 to 71.8 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.

Outcome measures

Outcome measures
Measure	Short Stem Group n=27 Participants Short femoral stem Taperloc short length stem	Long Stem Group n=33 Participants standard-length stem Taperloc standard length stem
Mean VR-12 Physical Composite Score Through 2 Years Post Operative VR-12 PCS Mean Score (Pre-Op)	25.2 T-Score Standard Deviation 6.8	23.6 T-Score Standard Deviation 5.3
Mean VR-12 Physical Composite Score Through 2 Years Post Operative VR-12 PCS Mean Score (6 wk)	37.0 T-Score Standard Deviation 10.0	37.8 T-Score Standard Deviation 9.8
Mean VR-12 Physical Composite Score Through 2 Years Post Operative VR-12 PCS Mean Score (3 mo)	42.1 T-Score Standard Deviation 10.2	40.1 T-Score Standard Deviation 10.6
Mean VR-12 Physical Composite Score Through 2 Years Post Operative VR-12 PCS Mean Score (6 mo)	45.8 T-Score Standard Deviation 10.0	44.7 T-Score Standard Deviation 9.5
Mean VR-12 Physical Composite Score Through 2 Years Post Operative VR-12 PCS Mean Score (1 yr)	48.7 T-Score Standard Deviation 10.9	49.5 T-Score Standard Deviation 8.3
Mean VR-12 Physical Composite Score Through 2 Years Post Operative VR-12 PCS Mean Score (2 yr)	45.1 T-Score Standard Deviation 11.3	48.5 T-Score Standard Deviation 5.2

PRIMARY outcome

Timeframe: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Behavior domain higher scores indicate more frequent and severe incidence of pain during daily activities

Outcome measures

Outcome measures
Measure	Short Stem Group n=27 Participants Short femoral stem Taperloc short length stem	Long Stem Group n=33 Participants standard-length stem Taperloc standard length stem
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative Pain Behavior T-Score (1 yr)	45.2 T-Score Standard Deviation 11.0	45.2 T-Score Standard Deviation 9.8
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative Pain Behavior T-Score (Pre-Op)	59.2 T-Score Standard Deviation 6.5	61.3 T-Score Standard Deviation 4.2
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative Pain Behavior T-Score (6 wk)	51.9 T-Score Standard Deviation 9.1	51.0 T-Score Standard Deviation 10.4
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative Pain Behavior T-Score (3 mo)	48.0 T-Score Standard Deviation 10.1	52.0 T-Score Standard Deviation 8.8
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative Pain Behavior T-Score (6 mo)	47.6 T-Score Standard Deviation 10.5	47.4 T-Score Standard Deviation 10.8
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative Pain Behavior T-Score (2 yr)	43.8 T-Score Standard Deviation 10.8	40.3 T-Score Standard Deviation 8.7

PRIMARY outcome

Timeframe: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Physical Function domain higher scores indicated improved physical function as reported by the patient

Outcome measures

Outcome measures
Measure	Short Stem Group n=27 Participants Short femoral stem Taperloc short length stem	Long Stem Group n=33 Participants standard-length stem Taperloc standard length stem
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative Physical Function T-Score (Pre-Op)	29.6 T-Score Standard Deviation 5.8	31.7 T-Score Standard Deviation 6.2
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative Physical Function T-Score (6 wk)	41.00 T-Score Standard Deviation 7.8	42.6 T-Score Standard Deviation 8.00
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative Physical Function T-Score (3 mo)	45.5 T-Score Standard Deviation 8.3	45.4 T-Score Standard Deviation 9.5
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative Physical Function T-Score (6 mo)	47.4 T-Score Standard Deviation 8.6	47.9 T-Score Standard Deviation 8.0
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative Physical Function T-Score (1 yr)	48.3 T-Score Standard Deviation 8.8	51.1 T-Score Standard Deviation 7.1
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative Physical Function T-Score (2 yr)	52.9 T-Score Standard Deviation 12.1	53.9 T-Score Standard Deviation 9.7

PRIMARY outcome

Timeframe: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Interference domain higher scores indicated greater impact on patient's ability to perform daily activities and social function

Outcome measures

Outcome measures
Measure	Short Stem Group n=27 Participants Short femoral stem Taperloc short length stem	Long Stem Group n=33 Participants standard-length stem Taperloc standard length stem
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative Pain Interference T-Score (Pre-Op)	64.6 T-Score Standard Deviation 8.6	67.4 T-Score Standard Deviation 6.5
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative Pain Interference T-Score (6 wk)	51.7 T-Score Standard Deviation 10.3	53.1 T-Score Standard Deviation 9.6
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative Pain Interference T-Score (3 mo)	49.7 T-Score Standard Deviation 10.1	51.1 T-Score Standard Deviation 10.1
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative Pain Interference T-Score (6 mo)	47.9 T-Score Standard Deviation 9.8	46.6 T-Score Standard Deviation 10.6
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative Pain Interference T-Score (1 yr)	48.00 T-Score Standard Deviation 10.5	44.0 T-Score Standard Deviation 8.3
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative Pain Interference T-Score (2 yr)	46.7 T-Score Standard Deviation 10.5	42.2 T-Score Standard Deviation 6.0

SECONDARY outcome

Timeframe: Assessed 6 weeks post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

EBRA-FCA is a commonly employed technique to evaluate implant migration via radiographic measurements taken over the duration of recovery. The mean subsidence values measured in millimeters were recorded for both the short and standard stem cohorts at each of the clinic visits for SOC. Of note, the individual responsible for performing and recording these measurements could not be reached during upload of the final study data and consequently the dispersion values for this measure were not available at the time of publication. The dispersion values for these measures have been recorded as '0' for each time point pending any response from the individual to obtain the original data.

Outcome measures

Outcome measures
Measure	Short Stem Group n=21 Participants Short femoral stem Taperloc short length stem	Long Stem Group n=20 Participants standard-length stem Taperloc standard length stem
EBRA (Ein-Bild-Roentgen-Analyse) Femoral Component Analysis (EBRA-FCA) of Implant Subsidence Through 2 Years Post Operative Femoral Stem Subsidence (6 wk)	0.124 millimeters Standard Deviation 0.961	0.193 millimeters Standard Deviation 0.533
EBRA (Ein-Bild-Roentgen-Analyse) Femoral Component Analysis (EBRA-FCA) of Implant Subsidence Through 2 Years Post Operative Femoral Stem Subsidence (6 mo)	0.448 millimeters Standard Deviation 1.200	0.702 millimeters Standard Deviation 1.080
EBRA (Ein-Bild-Roentgen-Analyse) Femoral Component Analysis (EBRA-FCA) of Implant Subsidence Through 2 Years Post Operative Femoral Stem Subsidence (1 yr)	0.526 millimeters Standard Deviation 1.653	1.303 millimeters Standard Deviation 1.264
EBRA (Ein-Bild-Roentgen-Analyse) Femoral Component Analysis (EBRA-FCA) of Implant Subsidence Through 2 Years Post Operative Femoral Stem Subsidence (2 yr)	0.590 millimeters Standard Deviation 1.072	1.414 millimeters Standard Deviation 1.547

Adverse Events

Short Stem Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Long Stem Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Manning, MD

Northwestern University

Phone: 312-695-6800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place