Trial Outcomes & Findings for A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial (NCT NCT01993615)

Results Overview

The Hip Outcome Score is designed to assess higher-level activities (i.e. those required in athletics) and has demonstrated validity in a study of patients at a mean of three years following hip arthroscopy. Additionally, a 2011 study states that the HOS has the greatest amount of clinimetric evidence (rigor of rating scales and indexes for the description of clinical phenomena). Only three published patient-reported outcome instruments utilized to assess FAI and labral pathology use clinimetric evidence and the HOS was identified as the most proven instrument. The HOS ADL Subscale consisted of 19 questions, each scored on a 5-point scale from 0 (unable to do) to 4 (no difficulty). The final score is calculated by taking the raw score, dividing it by the number of total questions answered multipled by 4 x 100 for a final score that ranges from 0 to 100%, with lower scores associated with greater limitation in Activities of Daily Living (ADL).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

24 months

Results posted on

2020-08-14

Participant Flow

Recruitment occurred from the orthopaedic clinic at Madigan Army Medical Center

Participant milestones

Participant milestones
Measure	Arthroscopic Surgery Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy. Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.	Physical Therapy An impairment-based supervised in-clinic physical therapy program. Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.
Overall Study STARTED	40	40
Overall Study COMPLETED	39	40
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arthroscopic Surgery Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy. Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.	Physical Therapy An impairment-based supervised in-clinic physical therapy program. Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.
Overall Study Death	1	0

Baseline Characteristics

A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arthroscopic Surgery n=40 Participants Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy. Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.	Physical Therapy n=40 Participants An impairment-based supervised in-clinic physical therapy program. Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.	Total n=80 Participants Total of all reporting groups
Age, Continuous	29.7 years STANDARD_DEVIATION 7.4 • n=5 Participants	30.6 years STANDARD_DEVIATION 7.4 • n=7 Participants	30.1 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Intention to treat analysis including only participants that received any treatment (6 participants that were enrolled never returned for treatment)

The Hip Outcome Score is designed to assess higher-level activities (i.e. those required in athletics) and has demonstrated validity in a study of patients at a mean of three years following hip arthroscopy. Additionally, a 2011 study states that the HOS has the greatest amount of clinimetric evidence (rigor of rating scales and indexes for the description of clinical phenomena). Only three published patient-reported outcome instruments utilized to assess FAI and labral pathology use clinimetric evidence and the HOS was identified as the most proven instrument. The HOS ADL Subscale consisted of 19 questions, each scored on a 5-point scale from 0 (unable to do) to 4 (no difficulty). The final score is calculated by taking the raw score, dividing it by the number of total questions answered multipled by 4 x 100 for a final score that ranges from 0 to 100%, with lower scores associated with greater limitation in Activities of Daily Living (ADL).

Outcome measures

Outcome measures
Measure	Arthroscopic Surgery n=37 Participants Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy. Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.	Physical Therapy n=37 Participants An impairment-based supervised in-clinic physical therapy program. Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.
Hip Outcome Score - ADL Subscale at 24 Months	69.3 score on a scale Interval 62.5 to 76.2	73.1 score on a scale Interval 66.1 to 80.3

PRIMARY outcome

Timeframe: 24 months

Population: Intention to treat analysis including only participants that received any treatment (6 participants that were enrolled never returned for treatment)

The Hip Outcome Score is designed to assess higher level activities (i.e. those required in athletics) and has demonstrated validity in a study of patients at a mean of three years following hip arthroscopy. Additionally, a 2011 study states that the HOS has the greatest amount of clinimetric evidence (rigor of rating scales and indexes for the description of clinical phenomena). Only three published patient-reported outcome instruments utilized to assess FAI and labral pathology use clinimetric evidence and the HOS was identified as the most proven instrument. The HOS Sport Subscale consists of 9 questions, each scored on a 5-point scale from 0 (unable to do) to 4 (no difficulty). The final score is calculated by taking the raw score, dividing it by the number of total questions answered multipled by 4 x 100 for a final score that ranges from 0 to 100%, with lower scores associated with greater limitations in Sports-related activities.

Outcome measures

Outcome measures
Measure	Arthroscopic Surgery n=37 Participants Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy. Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.	Physical Therapy n=37 Participants An impairment-based supervised in-clinic physical therapy program. Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.
Hip Outcome Score - Sport Subscale at 24 Months	55.3 score on a scale Interval 46.2 to 64.4	57.1 score on a scale Interval 47.8 to 66.3

SECONDARY outcome

Timeframe: 24 months

Population: Intention to treat analysis including only participants that received any treatment (6 participants that were enrolled never returned for treatment)

The iHOT33 is a quality-of-life patient-reported outcome measure that uses a visual analog scale response format for young, active patients with hip pathology. This 33-item questionnaire includes four sections: symptoms and functional limitations, sports and recreational activities, job related concerns and social, emotional and lifestyle concerns. This outcome measure has shown to be reliable; shows face, content and contrast validity and is highly responsive to clinical change. It uses a visual analog scale with the verbal anchors "no problems at all" on the far right and "significantly impaired" on the left. The total score is calculated as a simple mean of the responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.

Outcome measures

Outcome measures
Measure	Arthroscopic Surgery n=37 Participants Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy. Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.	Physical Therapy n=37 Participants An impairment-based supervised in-clinic physical therapy program. Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.
Group Differences in International Hip Outcome Score (IHOT33) to 24 Months	51.2 score on a scale Interval 42.5 to 59.9	44.9 score on a scale Interval 35.9 to 53.9

SECONDARY outcome

Timeframe: 24 months

The GROC will be administered to patients at the 6 months, one year and two year time points. The GROC questionnaire is a common, feasible, and useful method for assessing short term outcomes and overall changes in quality of life and is a valid measurement of change in patient status in a variety of pain populations. The GROC has a 15-point scale with a change of positive three points or higher (3+) demonstrating clinically significant improvement in a patient's perception of quality of life. Scores of -1 to -7 indicate negative perception of improvement (worsening of condition), a 0 indicates no change, and scores of +1 through +7 indicate a positive perceived improvement in the patients condition.

Outcome measures

Outcome measures
Measure	Arthroscopic Surgery n=37 Participants Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy. Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.	Physical Therapy n=37 Participants An impairment-based supervised in-clinic physical therapy program. Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.
Global Rating of Change Score of 3+ or Higher (Minimum Clinically Important Change)	16 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The Self-Motivation Inventory is an outcome measure that was developed to determine level of motivation. The Self-Motivation Inventory is a 40-item tool that has been found to measure an individual's tendency to persevere independent of situational reinforcement. It has also been used to predict successful weight loss and may correlate with number of sessions attended in weight loss program \[29\]. This tool underwent refinement in 1980 with the original 60-item tool being tested in undergraduate male and females. Items correlating less than 0.30 were deleted. The final 40-item scale yielded an exceptionally high internal reliability (α = 0.91) suggesting that a unitary common concept is evident for the obtained factor structure. The tool is widely used and has been tested in weight loss and therapeutic exercise studies

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

The PCS is a 13-item patient-report scale developed to measure the extent to which people catastrophize in response to pain. Each item is scored from 0 ('not at all') to 4 ('all the time'). The PCS is reported as a total score, with higher scores indicating greater catastrophizing, and is composed of three sub-scales: Rumination (four items; e.g. 'When I am in pain, I keep thinking about how badly I want the pain to stop'), Magnification (three items; e.g. 'When I am in pain, I become afraid that the pain will get worse'), and Helplessness (six items; e.g. 'When I am in pain, I feel I can't go on'). The PCS has been shown to have high levels of internal consistency and construct validity.

Outcome measures

Outcome data not reported

Adverse Events

Arthroscopic Surgery

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Physical Therapy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arthroscopic Surgery n=40 participants at risk Arthroscopic surgery at the femoroacetabular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy. Arthroscopic Surgery: The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.	Physical Therapy n=40 participants at risk An impairment-based supervised in-clinic physical therapy program. Physical Therapy: Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.
Injury, poisoning and procedural complications Surgical complication	5.0% 2/40 • Number of events 2 • 2 years	5.0% 2/40 • Number of events 2 • 2 years

Additional Information

Daniel Rhon

Madigan Army Medical Center

Phone: 253-968-0780

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place