This is a multicenter, international, assessor and patient blinded clinical RCT with two
groups (primary aim). the HIPARTI Study with The design of this trial conforms to the
SPIRIT guidelines.
All patients with hip pain eligible for hip arthroscopy in our routine care pathways will
be identified in our outpatient clinics. Consultant orthopedic surgeons will determine a
patient's eligibility for the study (based on inclusion and exclusion criteria for the
study) and members of their team introduce the study to the patients and refer them to
the research coordinators for further information. Patients will be provided with oral
and written information about the study and be introduced to our consent form. If
interest continues the patient will be provided with further information and arrangements
will be made for a baseline appointment for assessment and consenting.
The baseline assessment appointments will occur within one month of the initial approach.
At the baseline appointment patients will meet with the research coordinator and the
independent research assistant/tester (physical therapist) who will be the blinded
tester. Patients will return their signed informed consent form and baseline questions
completed. Those who are not willing to participate in the RCT (HIPARTI Study), will be
asked if interested in being included in a prospective longitudinal cohort study
including similar baseline and follow-up tests as those in the RCT (this will be the HARP
Study with separate papers published). All patients in the HARP Study will undergo hip
arthroscopy surgery. The Australian site will include most of their patients in the HARP
Study, since the majority of orthopedic surgeons working privately will not participate
in the HIPARTI Study. Data collection will be performed electronically for both the
HIPARTI and the HARP Studies entering all data in the approved Checkware system
(www.checkware.no).
Each collaborating center will apply to the ethical committee and the Data Inspectorate
in each country/institution. Approval was confirmed for Oslo University Hospital
(HIPARTI) and Australia (HARP Study) in January 2016.
Randomization (HIPARTI) will occur prior to surgery, after final eligibility is
confirmed. Randomizations will be performed centrally using an automated computer
generated system. Block randomization and stratification for each center will be
performed.
All patients will undergo imaging (which may include CT scan or at least 1.5 Tesla
magnetic resonance imaging MRI) prior to the surgical assessment as part of routine care.
All patients will also undergo standardized radiographs of the hips and pelvis also as
part of routine care. Plain radiographs will be examined for evidence of osteoarthritis
as joint space narrowing, osteophytes, cysts and subchondral hypertrophy. Several
radiographic measurements will be performed among them: the alpha angle and lateral
center-edge angle will be determined for the presence of FAI. Radiographs will also be
part of follow-ups.
Participating orthopedic surgeons will be asked to coordinate their waiting lists to
ensure the hip arthroscopy patients are called for surgery in accordance with the study
protocol. Ideally, patients will complete their baseline assessment as close to the
randomized treatment as possible (within 1 months). In the event that surgery cannot be
performed within 1 month after baseline assessment, the same questions and assessments
completed at baseline will be completed again. The standard followed-ups at the 6 months
and 1 year include primary and secondary outcomes. One year is the primary end point
where randomization code will be broken according to a predefined published statistical
protocol (HIPARTI).
At all follow-ups the research coordinator/independent tester will attend. At the 6 month
follow-up an independent orthopedic surgeon will attend regularly and take care of
patients who are not satisfied. The aim is to use the following criteria as subjective
complaint: equal or worse than 10 points for the IHOT-33 score compared to baseline. All
patients can withdraw without giving a reason at any time (stated in the consent form
that all patients need to sign). An unblinded orthopedic surgeon will of course be able
to have access to the medical record regarding performed procedures at any time if need
for the health of the patient.
All patients (in both groups in the RCT (HIPARTI) as well as in the HARP study) will
undergo a postoperative rehabilitation program based on the best available evidence. Each
patient will be treated by physical therapists who will be trained and proficient in
post-hip arthroscopy rehabilitation. Rehabilitation will be delivered a minimum of 8
sessions over 3-months and then once a month for the following three months. Details of
rehabilitation are outlined in Appendix Rehabilitation. This contains a treatment
algorithm to guide clinical reasoning and progression of treatment (manual therapy,
exercises and education) through weeks 1-12.
Long term follow-ups will be performed at 2, 5 and 10 years Due to lack of studies
published within this field: clinical relevant differences as well as changes within
groups and SD are difficult to estimate. Our sample size calculations are based on
primary outcome iHOT 33 at 1 year: estimated effect-size to 0.6 and a power of 90, will
give 60 in each group, and with expected 15% dropout will give 138 patients in total.
Electronic randomization lists will be generated, and estimations of inclusion rates per
site are included. Statistical analysis procedures will be published and analysis
performed prior to opening the group allocation when all patients are included and
followed through to the 1 year follow-up (main outcome).