Trial Outcomes & Findings for Nonarthritic Hip Disease Evaluation And Treatment (NCT NCT03519087)

Results Overview

Participants will indicate their planned treatment(s)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

Post-evaluation, same-day (approximately 5-10min after evaluation)

Results posted on

2020-05-06

Participant Flow

No participants were excluded from the study before assignment to groups (interdisciplinary vs. standard)

Participant milestones

Participant milestones
Measure	Interdisciplinary Evaluation Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.	Standard Evaluation Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.	Posture and Movement Training Participants will receive six training sessions with a physical therapist over a 3-week period.	3-week Wait Period Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.	Observational Arm Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
Clinic Evaluation STARTED	55	57	0	0	0
Clinic Evaluation Received Assigned Intervention	54	57	0	0	0
Clinic Evaluation Confirmed Diagnosis by Physician	39	39	0	0	0
Clinic Evaluation COMPLETED	39	39	0	0	0
Clinic Evaluation NOT COMPLETED	16	18	0	0	0
Re-randomization for Treatment STARTED	39	39	0	0	0
Re-randomization for Treatment COMPLETED	12	7	0	0	0
Re-randomization for Treatment NOT COMPLETED	27	32	0	0	0
Laboratory Testing STARTED	0	0	6	6	7
Laboratory Testing Baseline Lab Testing	0	0	5	4	3
Laboratory Testing COMPLETED	0	0	4	2	1
Laboratory Testing NOT COMPLETED	0	0	2	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Interdisciplinary Evaluation Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.	Standard Evaluation Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.	Posture and Movement Training Participants will receive six training sessions with a physical therapist over a 3-week period.	3-week Wait Period Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.	Observational Arm Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
Clinic Evaluation Physician Decision	15	18	0	0	0
Clinic Evaluation Protocol Violation	1	0	0	0	0
Re-randomization for Treatment Withdrawal by Subject	25	29	0	0	0
Re-randomization for Treatment Not appropriate	2	3	0	0	0
Laboratory Testing Lost to Follow-up	0	0	2	3	6
Laboratory Testing Protocol Violation	0	0	0	1	0

Baseline Characteristics

Nonarthritic Hip Disease Evaluation And Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interdisciplinary Evaluation n=39 Participants Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.	Standard Evaluation n=39 Participants Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.	Total n=78 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 10 • n=5 Participants	41 years STANDARD_DEVIATION 11 • n=7 Participants	38 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	39 participants n=7 Participants	78 participants n=5 Participants
Decisional Conflict	35.0 units on a scale STANDARD_DEVIATION 19.6 • n=5 Participants	40.1 units on a scale STANDARD_DEVIATION 18.6 • n=7 Participants	37.6 units on a scale STANDARD_DEVIATION 19.2 • n=5 Participants

PRIMARY outcome

Timeframe: Post-evaluation, same-day (approximately 5-10min after evaluation)

Population: Participants from Period 1 (Clinic evaluation) were analyzed for this primary outcome measure based on interdisciplinary or standard evaluation. This outcome measure was not a planned outcome for Period 3 (Laboratory testing) and thus, values are not reported for posture and movement training, 3-week wait period, or observational groups.

Participants will indicate their planned treatment(s)

Outcome measures

Outcome measures
Measure	Interdisciplinary Evaluation n=39 Participants Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.	Standard Evaluation n=39 Participants Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.	Posture and Movement Training Participants will receive six training sessions with a physical therapist over a 3-week period.	3-week Wait Period Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.	Observational Arm Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
Treatment Plan Physical Therapy included in treatment plan	26 Participants	19 Participants	—	—	—
Treatment Plan Surgery included in treatment plan	19 Participants	19 Participants	—	—	—
Treatment Plan Injection included in treatment plan	13 Participants	21 Participants	—	—	—

PRIMARY outcome

Timeframe: Pre-evaluation, 10min Post-evaluation

Population: Participants from Period 1 (Clinic evaluation) were analyzed for this primary outcome measure based on interdisciplinary or standard evaluation. This outcome measure was not a planned outcome for Period 3 (Laboratory testing) and thus, values are not reported for posture and movement training, 3-week wait period, or observational groups.

Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome).

Outcome measures

Outcome measures
Measure	Interdisciplinary Evaluation n=39 Participants Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.	Standard Evaluation n=39 Participants Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.	Posture and Movement Training Participants will receive six training sessions with a physical therapist over a 3-week period.	3-week Wait Period Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.	Observational Arm Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
Decisional Conflict Pre-evaluation decisional conflict	35.0 units on a scale Standard Deviation 19.6	40.1 units on a scale Standard Deviation 18.6	—	—	—
Decisional Conflict Post-evaluation decisional conflict	10.2 units on a scale Standard Deviation 11.2	16.5 units on a scale Standard Deviation 13.6	—	—	—

SECONDARY outcome

Timeframe: Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)

Population: The orthopaedic surgeons (n=2) and one physical therapist (n=1) from the study were interviewed and number of responses during the interviews were totaled based on theme. Each provider could have multiple responses. These providers are not associated with a specific arm or group of patient participants.

Qualitative interviews will be conducted with study providers both before patient participant enrollment and after study completion to collect information on how they feel about the evaluation protocols. Qualitative analysis of this data will count responses based on themes. Data for this report will be provided as the total number of responses (across all providers) that fell within each theme at both time points. Each provider could provide multiple responses.

Outcome measures

Outcome measures
Measure	Interdisciplinary Evaluation n=3 Participants Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.	Standard Evaluation n=3 Participants Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.	Posture and Movement Training Participants will receive six training sessions with a physical therapist over a 3-week period.	3-week Wait Period Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.	Observational Arm Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
Themes From Provider Interviews Implementation	11 number of responses for each theme	13 number of responses for each theme	—	—	—
Themes From Provider Interviews Interdisciplinary Evaluation	10 number of responses for each theme	13 number of responses for each theme	—	—	—
Themes From Provider Interviews Time	6 number of responses for each theme	8 number of responses for each theme	—	—	—
Themes From Provider Interviews Patient Response	12 number of responses for each theme	11 number of responses for each theme	—	—	—
Themes From Provider Interviews Clinical Reasoning	7 number of responses for each theme	9 number of responses for each theme	—	—	—
Themes From Provider Interviews Environment	2 number of responses for each theme	5 number of responses for each theme	—	—	—

SECONDARY outcome

Timeframe: 20min post-evaluation, 4 weeks post-evaluation

Population: Data were not collected.

Participants will be interviewed to collect information on how they feel about the 1) evaluation protocol(s) and 2) treatment/wait period protocols.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10min post-evaluation, 4-week laboratory visit

Population: Participants from Period 3 (Laboratory testing) were analyzed for this secondary outcome measure based on treatment group (Posture \& movement training, wait period, or observational). This outcome measure was not a planned follow-up outcome for Period 1 (Clinic evaluation) and thus, values are not reported for interdisciplinary and standard groups.

Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome). Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants' post-evaluation surveys from Period 1 (clinic evaluation).

Outcome measures

Outcome measures
Measure	Interdisciplinary Evaluation n=4 Participants Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.	Standard Evaluation n=2 Participants Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.	Posture and Movement Training n=1 Participants Participants will receive six training sessions with a physical therapist over a 3-week period.	3-week Wait Period Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.	Observational Arm Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
Decisional Conflict Post-evaluation decisional conflict	13.2 units on a scale Standard Deviation 10.3	14.8 units on a scale Standard Deviation 20.9	0 units on a scale Standard Deviation 0	—	—
Decisional Conflict 4-week decisional conflict	14.0 units on a scale Standard Deviation 16.2	13.2 units on a scale Standard Deviation 9.9	0.0 units on a scale Standard Deviation 0.0	—	—

SECONDARY outcome

Timeframe: 10min post-evaluation, 4-week laboratory visit

Population: Participants from Period 3 (Laboratory testing) were analyzed for this secondary outcome measure based on treatment group (Posture \& movement training, wait period, or observational). This outcome measure was not a planned follow-up outcome for Period 1 (Clinic evaluation) and thus, values are not reported for interdisciplinary and standard groups.

Participants will complete validated, reliable surveys for hip function (the Hip Outcome Score Activities of Daily Living \[HOSADL\] was used and is scored from 0-100 with 0 representing the worst function and 100 representing the best function). Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants' post-evaluation surveys from Period 1 (clinic evaluation).

Outcome measures

Outcome measures
Measure	Interdisciplinary Evaluation n=4 Participants Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. Interdisciplinary Evaluation for Nonarthritic Hip Disease: The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.	Standard Evaluation n=2 Participants Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant.	Posture and Movement Training n=1 Participants Participants will receive six training sessions with a physical therapist over a 3-week period.	3-week Wait Period Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time.	Observational Arm Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period.
Patient-reported Hip Function Post-evaluation HOSADL	52.9 units on a scale Standard Deviation 21.7	72.6 units on a scale Standard Deviation 29.8	89.0 units on a scale Standard Deviation 0	—	—
Patient-reported Hip Function 4-week HOSADL	68.2 units on a scale Standard Deviation 20.0	77.2 units on a scale Standard Deviation 25.9	92.6 units on a scale Standard Deviation 0	—	—

SECONDARY outcome

Timeframe: Baseline laboratory visit, 4-week laboratory visit

Population: Movement mechanics were not a planned variable for Period 1 (Clinic evaluation), but were a planned secondary variable for Period 3 (Laboratory testing). Collected data for the 7 participants who completed 4-week testing required extensive processing and resources that were not available due to loss of funding and personnel.

3-dimensional movement mechanics will be collected during functional tasks including walking and rising from a chair

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of enrollment, after all evaluations are complete

Participants will report decision regret related to their treatment plans

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Participants will report decision regret related to their treatment plans

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Strength of hip abductors, adductors, flexors, extenders, internal and external rotators will be collected during maximal voluntary isometric contractions

Outcome measures

Outcome data not reported

Adverse Events

Interdisciplinary Evaluation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Evaluation

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

Dr. Stephanie Di Stasi

The Ohio State University

Phone: 614-685-9779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place