A randomized controlled trial protocol for an interdisciplinary evaluation of non-arthritic hip disease

Abstract

Background:

Non-arthritic hip disease (NAHD) is a clinical condition often accompanied by painful movement. Current literature is lacking regarding how movement abnormalities are evaluated and treated in this population, which may be key to identifying which patients may respond to non-operative versus operative treatment. Combining the expertise of a hip arthroscopist and physical therapist may better inform treatment decisions for persons with NAHD. The primary objective of this study is to identify the extent to which an interdisciplinary evaluation between a physical therapist and surgeon influences treatment decisions of persons presenting to a hip preservation clinic.

Rationale for study design:

A prospective, randomized controlled trial provides the ability to identify cause and effect of this new evaluation type.

Methods:

Ninety-six adults with unilateral, NAHD presenting to a hip preservation clinic for initial evaluation will be randomized to receive either a standard evaluation with a surgeon or an interdisciplinary evaluation by a physical therapist and surgeon. Regardless of group, the surgeon conducts a standard-care examination. For participants in the interdisciplinary group, the physical therapist conducts an assessment of 6 postures and movements to identify asymmetrical, abnormal, or painful strategies. Treatment selection(s) and decisional conflict will be compared between groups after the evaluations.

Discussion:

Persons with NAHD may experience considerable decisional conflict because of prolonged duration of symptoms and minimal evidence to compare operative and non-operative treatment for this population. The findings of this study have the potential to improve patient experience and produce more informed and supported treatment decisions for persons considering surgical treatment for NAHD.

Introduction

Non-arthritic hip disease (NAHD) is a clinical condition inclusive of several intra-articular hip pathologies (femoroacetabular impingement, labral tear, cartilage defects and borderline acetabular dysplasia [1]), painful joint motion, reduced function, weakness and abnormal movement [1,2]. Hip arthroscopy has gained increasing popularity as the gold standard treatment option for NAHD [3]. Despite statistically significant improvements in function, a large systematic review and meta-analysis showed only 1 in 4 persons who have undergone hip arthroscopy report acceptable levels of patient-reported daily hip function 2 years post-operatively [4]. Nonoperative management may offer an effective alternative to surgical management for some individuals. However, in the current clinical model where patients are evaluated by a surgeon only, the patient may not understand the potential value of a non-operative approach and therefore select surgery prior to attempting non-operative management. Methods to comprehensively evaluate patients and support patients in their decision for operative or non-operative interventions may improve patient satisfaction with their treatment and, potentially, achievement of patient-acceptable symptomatic states.

Historically, physical therapy treatment for NAHD has been focused on stretching, strengthening and joint mobility [5–7], but more recent physical therapy protocols have incorporated movement training [8,9]. Because patients with NAHD often present with abnormal movement patterns during functional tasks [10–20], physical therapy assessment specifically focused on posture and movement may be a crucial step to identify patients who stand to benefit from movement-focused treatment. Approximately half of hip arthroscopists recommend physical therapy as a first-line treatment for NAHD, indicating that many patients elect to have surgery without trying non-operative management [21]. The expertise of physical therapists as movement specialists can uniquely contribute to the assessment of patients with NAHD.

In a feasibility study to estimate enrollment rates in a trial comparing surgical and non-surgical treatments for femoroacetabular impingement syndrome, a type of NAHD, 71% of patients considering hip arthroscopy for NAHD reported their treatment decision was most influenced by physician recommendation [22]. Interestingly, the majority of these patients indicated no strong treatment preference, suggesting an opportunity for interdisciplinary collaboration between physicians and physical therapists to inform treatment decisions. Patients with NAHD, who often see an average of 4 providers before diagnosis [23], may experience decisional conflict when deciding between operative and non-operative treatment. Decisional conflict is a measure of uncertainty experienced by a decision-maker and is predictive of delay and changes for medical treatment decisions [24,25]. A shared decision-making process that includes perspectives from the patient, physician and physical therapist may not only inform treatment decisions but also reduce decisional conflict.

Decision support interventions are of increasing interest in the medical field [26], including shared decision-making. A systematic review of 24 articles concluded that shared decision-making resulted in reduced decisional conflict and improved decision quality for persons who made decisions regarding elective surgical care for a variety of conditions, including orthopaedic joint surgery [27]. Providing a comprehensive evaluation of joint pathology and clinical presentation (including movement patterns) may better inform treatment decisions of patients with NAHD. Furthermore, this collaboration across multiple providers and the patient may optimize patient experience and improve satisfaction with treatment decisions.

Objective

The proposed randomized, controlled trial will test the primary hypothesis that the inclusion of both a surgeon and physical therapist in the evaluation of individuals with NAHD will result in (1) increased likelihood of the participant to include physical therapy in their treatment selection and (2) reduced decisional conflict reported by participants regarding their treatment selection(s).

Methods

Study Design - General Overview

This protocol describes a prospective, randomized controlled trial to understand how an interdisciplinary shared decision-making process impacts treatment selection and decisional conflict for persons with NAHD. All participants will complete an informed consent process approved by the institutional review board at the study institution. Participants will be randomized to receive either a standard (STAND) evaluation with a hip arthroscopist or an interdisciplinary (INT) evaluation with a hip arthroscopist and a physical therapist (Figure 1). Participants will complete surveys regarding their expected treatment selection prior to any evaluation. After all evaluation(s) are complete, all participants complete surveys to capture previous treatment, history of injury, current function and the participants’ treatment selection.

Figure 1. Study Design.

This diagram provides visualization for how participants may navigate arms of the trial. STAND=standard, INT=interdisciplinary

Participants

Participants will be recruited from a hip preservation clinic at the study institution, led by 2 orthopaedic surgeons (5 and 3 years of post-fellowship; 150 and 125 hip arthroscopies per year) who both completed fellowships in hip arthroscopy. Adult patients listed as new evaluations for hip pain will be approached for participation as outlined in Table 1.

Table 1.

Participant Eligibility

Inclusion criteria:
• At least one form of intra-articular hip pathology, including any combination of:   • Femoroacetabular impingement [FAI]   • Labral tear   • Cartilage defects   • Acetabular dysplasia  • Unilateral hip joint or groin pain  • Groin pain reproduced with least one of the following: [1]   • Hip flexion, adduction and internal rotation (FADIR)   • Hip flexion, abduction and external rotation (FABER)  • 18 years of age, or older  • Legally able to make independent medical decisions
Exclusion criteria:
• Extra-articular hip pathology (i.e. muscle or tendon pathology)  • Spine pathology (e.g., nerve root impingement, herniated disc, scoliosis)  • Hip osteoarthritis (Tonnis grade >2) [34]  • Inflammatory disease, rheumatoid arthritis, gout  • Osteoporosis  • Systemic health condition  • Current pregnancy  • Previous hip surgery or fracture  • Severe deformities, Legg-Calve-Perthes disease, slipped capital femoral epiphysis  • Presence of cancer  • Current injury to the spine or lower extremity requiring medical attention*  • Bilateral hip pain (at least 4/10 pain on both hips)  • Periacetabular osteotomy candidate (LCEA <20°, ACEA <18°, acetabular index >10) [35]  • Uninsured

LCEA = lateral center edge angle; ACEA = anterior center edge angle

^*Participants with concomitant low back pain will be included in the study unless spinal pathology is identified.

Sample size estimate

Sample size was calculated a priori to detect a significant difference between groups for the proportion of participants who include physical therapy in their treatment selection after their evaluation(s). Based on the assumption that 30% of control participants and 60% of intervention participants will include physical therapy in their treatment plan, we estimated that a total sample size of 96 participants would be needed to detect group differences with 85% power with at a one-sided significance level of 0.025. A sample size calculation for decisional conflict was not performed because no appropriate prior data were available. Decisional conflict data will be collected for exploratory analyses.

Intervention

Standard (STAND) Evaluation

One of 2 fellowship-trained hip arthroscopists confirms inclusion and exclusion criteria (Table 1) during a standard-care examination (Table 2), then proceeds to review treatment recommendation(s), answer questions and instruct the participant regarding next steps.

Table 2.

Physician Examination

Subjective	Past medical history Pain history Activity limitations Participation restrictions
Physical examination	Hip strength Passive and active range of motion of the hip Pain provocation tests (FADIR, FABER) Passive and active range of motion of the knee Knee strength
Movement clearing	Single-leg stance Walking gait
Imaging	Well centered AP pelvis AP hip Dunn lateral hip False profile hip

AP = anterior; posterior

Interdisciplinary (INT) Evaluation

This evaluation starts with the same examination by the surgeon (Table 2), but does not include a discussion of treatment recommendations. Instead, after the surgeon has completed the examination, the participant will be examined by a physical therapist (6 years clinical experience, sports residency trained) whose clinical treatment schedule is approximately 40% patients with NAHD. This examination includes assessment of 6 postures and movements (Table 3) commonly evaluated during biomechanical assessment of functional daily activity [8,13,28–30]. After leaving the examination room, the physical therapist provides a 30-second report of the posture and movement assessment to the surgeon and if physical therapy treatment is recommended. In return, the surgeon provides a 30-second report of examination findings and treatment recommendations. Both providers take approximately one minute to jointly discuss a plan of care. The providers are not required to agree on a single recommendation. If both providers agree on recommendation(s), the surgeon reviews the final recommendation(s) with the participant; the physical therapist will be in the examination room to provide additional information and answer questions. If the providers disagree on recommendations, the surgeon, then physical therapist, provide their respective recommendations and rationale to the participant, then allow time for questions and discussion. After discussing expected benefits and potential limitations of each recommendation with the participant, the providers instruct the participant regarding next steps for clinical care. In both scenarios, the surgeon provides recommendations first, as the provider with whom the participant initially scheduled an evaluation.

Table 3.

Physical Therapy Examination

	Yes	No
Seated Posture
Asymmetrical weight shift
Anterior pelvic tilt
Posterior pelvic tilt
Crossed legs (at knees)
Pain
Sit-to-Stand (arms crossed at chest)
Unable to stand without hands
Frontal plane asymmetry (lateral weight shift)
Knee valgus
Excessive trunk flexion
Pain
Standing Posture
Posterior trunk lean
Anterior pelvic tilt / excessive lumbar lordosis
Knee hyperextension
Lateral weight shift
Pain
Single-leg Stance (arms crossed at chest)
Pelvic drop or tilt
Frontal plane trunk lean
Loss of balance
Arms break from crossed at chest
Pain
Single-leg Squat (arms crossed at chest; thighs parallel)
Knee valgus or varus
Pelvic drop or tilt
Frontal plane trunk lean
Loss of balance
Arms break from crossed at chest
Pain
Walking gait; 15ft
Anterior pelvic tilt / excessive lumbar lordosis
Excessive hip extension (i.e. over-striding)
Trendelenburg gait (swinging hips)
Frontal plane trunk lean
Knee hyperextension
Pain
Forward Step-up and Tap-down* (from 6 inch step)
Knee valgus or varus
Pelvic drop or tilt
Frontal plane trunk lean
Loss of balance
Arms break from crossed at chest
Pain
Participant-specific movement
Asymmetry
Poor mechanics
Pain

^*Only preformed if normal movement is noted for single-leg squat

Treatment Fidelity

The hip arthroscopists and the physical therapist completed 3 in-person training sessions with the study team and principal investigator, ranging from 30–60 minutes to review the study protocol, standardize the examination techniques for the surgeons and physical therapist and standardize what information will be shared with each other prior to discussing treatment recommendations with participants in the INT group.

Intervention outcomes

Patient-reported outcomes will be recorded to capture treatment selection and decisional conflict as primary outcomes and patient history and hip function as secondary outcomes (Table 4). Providers will record treatment recommendations as secondary outcomes to inform future studies regarding patient-provider agreement. Time spent completing surveys, waiting on providers and during examination(s) will be recorded. Number of patients approached for participation, number of patients who deny participation, reason for denial, number of patients who enroll, number of patients excluded and reason for exclusion will be recorded.

Table 4.

Outcome Measures Completed Before and After Evaluation(s)

	Pre	Post
Primary Patient-reported
Treatment selection	X	X	Custom online survey (Figure 2) to indicate treatment interests and selections
Decisional conflict	X	X	A measure of participant uncertainty regarding treatment selection [24]
Secondary Patient-reported
History		X	Custom online survey to capture previous treatment, symptom duration, activity level, and pain location
HOS-ADL		X	A measure of patient-reported hip function during daily activities [36,37]
iHOT33		X	A measure of patient-reported hip function across a variety of health domains [38]
HOS-S		X	A measure of patient-reported athletic hip function, only prompted for participants who indicate an activity level of at least light activities (jogging, low impact aerobics, or weight lifting) [36,37]
Oswestry Low Back Pain Disability Questionnaire		X	Patient-reported disability related to back pain, only prompted for participants who indicate concomitant back pain [39]
Secondary Provider-reported
Treatment recommendation		X	The MD and PT independently indicate their treatment recommendation(s)
Joint recommendation		X	The MD and PT indicate the joint treatment recommendation(s)
Recommendation confidence		X	The MD and PT independently indicate their confidence (0:100 sliding scale) that the recommended treatment will resolve patient symptoms
Confidence re: joint recommendation		X	The MD and PT independently indicate their confidence (0:100 sliding scale) that the joint treatment recommendation will resolve patient symptoms

Intervention assignment

Assignment

A computer-generated randomization scheme with random block sizes from 2 to 8 was used to produce the assignment (STAND vs. INT) for the expected 128 patients who will enroll before unilateral NAHD is confirmed. Some participants will be excluded after randomization, which may affect the number of participants ultimately assigned to each group. We do not believe this will result in an imbalance between the groups, because we anticipate that equal numbers of participants will be excluded from each group after the surgeon confirms clinical inclusion and exclusion criteria. Based on current recruitment rates, we estimate 75% of enrolled participants will meet all criteria, leaving approximately 48 in each group after a 12-month recruitment period.

Blinding

It is not possible to blind the patient, the surgeons or the physical therapist completing the examinations. Research personnel involved in statistical analysis, including the principal investigator and biostatistician, will be blinded to the group.

Data collection, management and analysis

Data Collection and Management

Survey data will be collected and managed using Research Electronic Data Capture (REDCap™) electronic data capture tools hosted at the study institution [31]. REDCap™ is a secure, web-based application designed to support data capture for research studies. Research personnel will be present when participants complete surveys and have been instructed on standardized responses to participant questions. REDCap™ will also be used to record results from the posture and movement assessment (INT group only), provider recommendations, field notes and feasibility data. Data collected will be stored on secure networks at the study institution. Identifiable information will be stored separately from survey and laboratory data. Prior to data analysis, all data will be de-identified.

Statistical Analysis Plan

Prior to statistical analysis, assumptions of all tests will be confirmed; if assumptions are not confirmed, transformations or appropriate non-parametric tests will be performed. Chi-square analysis will be used to determine if participants in the INT group more often include physical therapy in their treatment selection (p≤0.025). Independent sample t-tests will be used to assess for differences in decisional conflict between groups (p≤0.05). Independent sample t-tests will be conducted to compare time spent during evaluation(s) between groups (p≤0.05). Exploratory analyses may further investigate time spent with each clinician and time spent waiting on clinicians. Descriptive statistics will be produced identifying the number of potential participants who declined participation and the number of participants excluded from each group.

Ethics

The biomedical institutional review board at the study institution has approved the informed consent process and study protocol, which is the first arm of a larger prospective trial ( NCT03519087). All research personnel have completed training in research ethics, participant safety and good clinical practice.

Results

At current recruitment rates (25% recruited after 3 months), recruitment will close in Spring 2019. Over a 3-month recruitment period, 43 potential participants have met pre-screen eligibility. Thirty-five (81%) of these potential participants enrolled in the study. Patients who were approached, but did not enroll, reported time constraint (n=3), previous negative experience with physical therapy (n=3), or preference for single provider care (n=2) as reasons they did not wish to participate. Twenty-four (68%) of the 35 enrolled participants met all inclusion and exclusion criteria. The 11 excluded participants were due to osteoarthritis (n=4), concomitant health conditions (n=l) or extra-articular hip pathology (n=6).

Discussion

This trial proposes a theoretical and practical shift to the current delivery of patient care for persons with NAHD. Traditionally persons with NAHD, after failing conservative medical treatment, seek consultation from an orthopaedic surgeon. Previous conservative treatment may have included physical therapy, but many have not focused on posture and movement training to address known deficits in this population. The proposed delivery method in this trial provides additional, movement-focused evaluation by a physical therapist to complement the surgeon’s evaluation resulting in a more comprehensive assessment of morphology and pathology. This interdisciplinary approach to NAHD has the potential to better identify appropriate surgical and non-surgical candidates, which may ultimately result in superior patient outcomes and satisfaction.

The collaboration between a surgeon and physical therapist may better inform patient decisions and improve patient experience. Multidisciplinary treatment between hip arthroscopists, physical therapists and psychologists resulted in both improved physical and mental functioning for adolescents who underwent hip preservation surgery [32]. While Richard et al. reported on the multidisciplinary treatment plan across these three disciplines, they did not describe any collaborative evaluation efforts or support of patient treatment decisions [32]. The proposed trial aims to first identify if interdisciplinary evaluation impacts treatment decisions, which may inform how interdisciplinary treatment can potentially improve patient outcomes.

While the proposed study will not directly measure patient satisfaction with their evaluation(s), the Decisional Conflict Scale captures uncertainty and quality of a decision, how informed and how supported a patient feels regarding a decision, and how patient values contribute to treatment decisions. This information will speak to patient satisfaction with their treatment selection after their evaluation(s). Because different patients may have different desired involvement in the decision-making process [33] this information will be critical to identify patients who may benefit from interdisciplinary evaluation to support a shared decision-making process.

Limitations

Participant recruitment may be limited based on patient history of physical therapy and the impact that may have on willingness to participate. This limitation could produce a biased sample of patients lacking those with previous history of physical therapy. Research personnel will explain how the evaluation as part of the trial may differ from previous physical therapy evaluations and may assist the patient to make a more informed treatment decision. Recruitment may also be limited by time constraints of patients. Additional time for surveys, physical therapy assessment and discussion with both providers, is estimated 15–30 minutes for those in the INT group.

Recruiting participants from the practices of two surgeons may produce variability in the results due to provider-specific nuisances in approaches to patient interaction, specifically for discussions regarding treatment recommendation. To minimize the variability, the physician examination has been standardized; however, no script will be used to standardize decision-making discussions. Sensitivity analyses may be conducted to evaluate any effect of a surgeon.

While our group anticipates adding a physical therapist will provide a more comprehensive evaluation to inform and support patient decision-making processes, the addition of a second provider may confuse participants. Provider recommendations are being recorded, including whether providers agree or disagree, to understand if disagreement results in more decisional conflict for the participant.

Conclusion

This study will investigate how evaluation by a physical therapist, focused on posture and movement, may inform treatment selection by patients with NAHD. This model of evaluation can inform the patient and surgeon if posture and movement deficits exist and if physical therapy treatment may be warranted. Treatment may be considered to inform surgical decisions or to optimize movement prior to surgical intervention. The collaborative efforts to discuss treatment options may improve identification of operative and non-operative candidates and subsequently improve patient outcomes.

Figure 2. Treatment Selection Survey.

This survey was developed to capture planned treatment of participants before and after their evaluation(s) with associated confidence in all treatment options. *Participants who select “other” from the initial treatment option list will be prompted to indicate their confidence that other treatment will improve their symptoms.