Hip DysplasiaPRSPAONCT02790749
Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy
A study testing Adjunctive hip arthroscopy to accompany PAO and PAO without adjunctive hip arthroscopy in people with Hip Dysplasia, run by Sharp HealthCare.
Trial summary
Although evidence is amassing regarding the role of intra-articular pathology in the surgical management of adolescents and adults with hip dysplasia, the optimal method of detection and especially management of this pathology remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- Adjunctive hip arthroscopy to accompany PAO and PAO without adjunctive hip arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18 to 50
- Moderate or severe dysplasia by radiographic parameters
- Physical examination and/or MR arthrography consistent with intra-articular pathology (equivocal or even negative MR arthrogram for labral tear, chondral flap, ligamentum teres tear, or osteochondral defect, is not grounds for exclusion, since broadly spaced "cuts" of MR imaging may miss small tears)
- English- or Spanish-speaking
- signed written informed consent for surgery and for research prior to surgery
Who cannot join
- Tönnis grade II or III arthritis at baseline
- MR cartilage imaging indicating severe arthritis
- Prior surgery on the same hip
- Contralateral lower limb pathology that threatens validity of outcomes measures directed at the operative hip
- History of thromboembolic disease in the lower extremity, pulmonary embolus, or pre-existing thrombophilic blood disorder
- Inability to participate in or comply with appropriate rehabilitation protocols
Show all 9Show fewer
- Inability to comprehend and follow instructions, or mental incapacity barring consent
- Pregnant women
- Lost to follow-up before one year, unless total hip replacement performed before one year (then included for survival analysis)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy for Intra-Articular Pathology in Hip Dysplasia: a Prospective Randomized Trial
Although evidence is amassing regarding the role of intra-articular pathology in the surgical management of adolescents and adults with hip dysplasia, the optimal method of detection and especially management of this pathology remains unclear. No studies exist to compare clinical outcomes and hip survival between arthroscopy and arthrotomy in patients with mechanical hip pain undergoing periacetabular osteotomy (PAO) for dysplasia, and this is what the investigators aim to achieve in the current prospective randomized surgical trial.
Read the detailed description
Developmental dysplasia of the hip is an increasingly well-recognized problem in adolescents, young adults, and middle-age adults. Surgical correction with periacetabular osteotomy (PAO) gives good results at moderate-term follow-up, according to recent studies. Increasingly recognized also is the presence of intra-articular sources of hip pain in these patients, such as cartilage disease and labral pathology. These can manifest as certain clinical and radiologic findings pre-operatively. However, the role of operative management of these problems, and specifically the role of arthroscopy, remains unclear. Historically, intra-articular pathology in patients with dysplasia has been managed with open incision of the joint capsule (arthrotomy) toward the end of the PAO procedure. However, recent evidence suggests that this open arthrotomy may be missing the detection of subtle intra-articular pathology and that arthroscopy immediately prior to PAO, under the same anesthetic, may be a safe and highly effective management strategy. The exact clinical implications of these subtle findings are not yet clear.
In this prospective randomized comparative effectiveness study, the investigators aim to compare clinical and surgical outcomes measures including rates of reoperation and the patient reported outcomes measures (PROMs) non-arthritic hip score (NAHS), Hip Outcome Score (HOS), modified Harris Hip Score (mHHS), iHOT-12 score, between two groups of patients (N=22 per parallel arm) undergoing PAO for dysplasia: those randomized to arthroscopy with PAO versus those randomized to PAO alone.
The investigators aim to elucidate the degree of clinical benefit of improved detection and management of intra-articular pathology afforded by arthroscopy versus PAO with arthrotomy alone at follow-up of a minimum of one year. Rates of reoperation and PROMs will be assessed at one year post-operatively and at the conclusion of the study two years after enrollment of the first patient. PROMs will also be assessed at 3 and 6 months post-operatively to allow repeated-measures analysis in measuring improvement from pre-operative values.
- Conditions
- Hip Dysplasia
- Being tested
- Adjunctive hip arthroscopy to accompany PAO, PAO without adjunctive hip arthroscopy
- Keywords
- Developmental hip dysplasia, Intra-articular pathology, Adult hip dysplasia, Labral tear, hip, Chondromalacia, hip
- Medical subject headings
- Hip Dislocation, Developmental Dysplasia of the Hip, Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive hip arthroscopy to accompany PAOProcedure or surgery
This is the experimental group: those patients who undergo adjunctive hip arthroscopy in addition to periacetabular osteotomy (PAO).
PAO without adjunctive hip arthroscopyProcedure or surgery
This is the control group: those patients who undergo periacetabular osteotomy (PAO) alone, without adjunctive hip arthroscopy.
| Study group | Role | What they receive |
|---|---|---|
| PAO with adjunctive hip arthroscopy | Experimental | Patients undergoing periacetabular osteotomy (PAO) with adjunctive hip arthroscopy. Receives: Procedure: Adjunctive hip arthroscopy to accompany PAO |
| PAO WITHOUT adjunctive hip arthroscopy | Active comparator | Patients undergoing periacetabular osteotomy (PAO) WITHOUT adjunctive hip arthroscopy. Receives: Procedure: PAO without adjunctive hip arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of reoperation by final follow-up
Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO
Measured: One year
NAHS (non-arthritic hip score)
Absolute value of, and measure of post-operative improvement in, validated questionnaire known as NAHS--Non-Arthritic Hip Score
Measured: One year
Secondary outcomes (3)
iHOT-12: 12-question version of the international Hip Outcome Tool
questionnaire known as iHOT-12: the 12-question version of the international Hip Outcome Tool
Measured: one year
HOS: Hip Outcome Score
questionnaire known as the HOS: Hip Outcome Score
Measured: one year
mHHS: Modified Harris Hip Score
questionnaire known as mHHS: Modified Harris Hip Score
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Muldoon, M.D., Sharp HealthCare
- Investigators
- Michael P Muldoon, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790749
- Sponsor's protocol ID
- 1603903
- Acronym
- PRSPAO
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ganz R, Leunig M, Leunig-Ganz K, Harris WH. The etiology of osteoarthritis of the hip: an integrated mechanical concept. Clin Orthop Relat Res. 2008 Feb;466(2):264-72. doi: 10.1007/s11999-007-0060-z. Epub 2008 Jan 10.
PubMed 18196405Klaue K, Durnin CW, Ganz R. The acetabular rim syndrome. A clinical presentation of dysplasia of the hip. J Bone Joint Surg Br. 1991 May;73(3):423-9. doi: 10.1302/0301-620X.73B3.1670443.
PubMed 1670443Siebenrock KA, Scholl E, Lottenbach M, Ganz R. Bernese periacetabular osteotomy. Clin Orthop Relat Res. 1999 Jun;(363):9-20.
PubMed 10379300Ganz R, Klaue K, Vinh TS, Mast JW. A new periacetabular osteotomy for the treatment of hip dysplasias. Technique and preliminary results. Clin Orthop Relat Res. 1988 Jul;(232):26-36.
PubMed 3383491Steppacher SD, Tannast M, Ganz R, Siebenrock KA. Mean 20-year followup of Bernese periacetabular osteotomy. Clin Orthop Relat Res. 2008 Jul;466(7):1633-44. doi: 10.1007/s11999-008-0242-3. Epub 2008 May 1.
PubMed 18449617Kemp JL, Collins NJ, Makdissi M, Schache AG, Machotka Z, Crossley K. Hip arthroscopy for intra-articular pathology: a systematic review of outcomes with and without femoral osteoplasty. Br J Sports Med. 2012 Jul;46(9):632-43. doi: 10.1136/bjsports-2011-090428. Epub 2011 Dec 22.
PubMed 22194221Clohisy JC, Schutz AL, St John L, Schoenecker PL, Wright RW. Periacetabular osteotomy: a systematic literature review. Clin Orthop Relat Res. 2009 Aug;467(8):2041-52. doi: 10.1007/s11999-009-0842-6. Epub 2009 Apr 21.
PubMed 19381741Davey JP, Santore RF. Complications of periacetabular osteotomy. Clin Orthop Relat Res. 1999 Jun;(363):33-7.
PubMed 10379302Thawrani D, Sucato DJ, Podeszwa DA, DeLaRocha A. Complications associated with the Bernese periacetabular osteotomy for hip dysplasia in adolescents. J Bone Joint Surg Am. 2010 Jul 21;92(8):1707-14. doi: 10.2106/JBJS.I.00829.
PubMed 20660233Ginnetti JG, Pelt CE, Erickson JA, Van Dine C, Peters CL. Prevalence and treatment of intraarticular pathology recognized at the time of periacetabular osteotomy for the dysplastic hip. Clin Orthop Relat Res. 2013 Feb;471(2):498-503. doi: 10.1007/s11999-012-2602-2.
PubMed 23054510Muldoon MP, Santore RF. Abstract presented at Western Orthopedic Association. Adjunctive Hip Arthroscopy with Periacetabular Osteotomy for Hip Dysplasia. 2007.
Fujii M, Nakashima Y, Noguchi Y, Yamamoto T, Mawatari T, Motomura G, Iwamoto Y. Effect of intra-articular lesions on the outcome of periacetabular osteotomy in patients with symptomatic hip dysplasia. J Bone Joint Surg Br. 2011 Nov;93(11):1449-56. doi: 10.1302/0301-620X.93B11.27314.
PubMed 22058293Domb BG, LaReau J, Redmond JM. Combined hip arthroscopy and periacetabular osteotomy: indications, advantages, technique, and complications. Arthrosc Tech. 2014 Jan 10;3(1):e95-e100. doi: 10.1016/j.eats.2013.09.002. eCollection 2014 Feb.
PubMed 24843847Ginnetti JG, Erickson J, Peters CL. Periacetabular osteotomy: intra-articular work. Instr Course Lect. 2013;62:279-86.
PubMed 23395033Ross JR, Zaltz I, Nepple JJ, Schoenecker PL, Clohisy JC. Arthroscopic disease classification and interventions as an adjunct in the treatment of acetabular dysplasia. Am J Sports Med. 2011 Jul;39 Suppl:72S-8S. doi: 10.1177/0363546511412320.
PubMed 21709035
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy for Intra-Articular Pathology in Hip Dysplasia: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02790749
- Acronym / sponsor ID
- PRSPAO / 1603903
- Conditions
- Hip Dysplasia
- Keywords
- Developmental hip dysplasia, Intra-articular pathology, Adult hip dysplasia, Labral tear, hip, Chondromalacia, hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although evidence is amassing regarding the role of intra-articular pathology in the surgical management of adolescents and adults with hip dysplasia, the optimal method of detection and especially management of this pathology remains unclear. No studies exist to compare clinical outcomes and hip survival between arthroscopy and arthrotomy in patients with mechanical hip pain undergoing periacetabular osteotomy (PAO) for dysplasia, and this is what the investigators aim to achieve in the current prospective randomized surgical trial.
Detailed description
Developmental dysplasia of the hip is an increasingly well-recognized problem in adolescents, young adults, and middle-age adults. Surgical correction with periacetabular osteotomy (PAO) gives good results at moderate-term follow-up, according to recent studies. Increasingly recognized also is the presence of intra-articular sources of hip pain in these patients, such as cartilage disease and labral pathology. These can manifest as certain clinical and radiologic findings pre-operatively. However, the role of operative management of these problems, and specifically the role of arthroscopy, remains unclear. Historically, intra-articular pathology in patients with dysplasia has been managed with open incision of the joint capsule (arthrotomy) toward the end of the PAO procedure. However, recent evidence suggests that this open arthrotomy may be missing the detection of subtle intra-articular pathology and that arthroscopy immediately prior to PAO, under the same anesthetic, may be a safe and highly effective management strategy. The exact clinical implications of these subtle findings are not yet clear.
In this prospective randomized comparative effectiveness study, the investigators aim to compare clinical and surgical outcomes measures including rates of reoperation and the patient reported outcomes measures (PROMs) non-arthritic hip score (NAHS), Hip Outcome Score (HOS), modified Harris Hip Score (mHHS), iHOT-12 score, between two groups of patients (N=22 per parallel arm) undergoing PAO for dysplasia: those randomized to arthroscopy with PAO versus those randomized to PAO alone.
The investigators aim to elucidate the degree of clinical benefit of improved detection and management of intra-articular pathology afforded by arthroscopy versus PAO with arthrotomy alone at follow-up of a minimum of one year. Rates of reoperation and PROMs will be assessed at one year post-operatively and at the conclusion of the study two years after enrollment of the first patient. PROMs will also be assessed at 3 and 6 months post-operatively to allow repeated-measures analysis in measuring improvement from pre-operative values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAO with adjunctive hip arthroscopy | Experimental | Procedure: Adjunctive hip arthroscopy to accompany PAOPatients undergoing periacetabular osteotomy (PAO) with adjunctive hip arthroscopy. |
| PAO WITHOUT adjunctive hip arthroscopy | Active comparator | Procedure: PAO without adjunctive hip arthroscopyPatients undergoing periacetabular osteotomy (PAO) WITHOUT adjunctive hip arthroscopy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ages 18 to 50
- Moderate or severe dysplasia by radiographic parameters
- Physical examination and/or MR arthrography consistent with intra-articular pathology (equivocal or even negative MR arthrogram for labral tear, chondral flap, ligamentum teres tear, or osteochondral defect, is not grounds for exclusion, since broadly spaced "cuts" of MR imaging may miss small tears)
- English- or Spanish-speaking
- signed written informed consent for surgery and for research prior to surgery
Key exclusion criteria (9 listed)
- Tönnis grade II or III arthritis at baseline
- MR cartilage imaging indicating severe arthritis
- Prior surgery on the same hip
- Contralateral lower limb pathology that threatens validity of outcomes measures directed at the operative hip
- History of thromboembolic disease in the lower extremity, pulmonary embolus, or pre-existing thrombophilic blood disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjunctive hip arthroscopy to accompany PAOThis is the experimental group: those patients who undergo adjunctive hip arthroscopy in addition to periacetabular osteotomy (PAO). | Procedure or surgery | PAO with adjunctive hip arthroscopy |
| PAO without adjunctive hip arthroscopyThis is the control group: those patients who undergo periacetabular osteotomy (PAO) alone, without adjunctive hip arthroscopy. | Procedure or surgery | PAO WITHOUT adjunctive hip arthroscopy |
Primary outcome
Incidence of reoperation by final follow-up
Time frame: One year
Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO
NAHS (non-arthritic hip score)
Time frame: One year
Absolute value of, and measure of post-operative improvement in, validated questionnaire known as NAHS--Non-Arthritic Hip Score
3 secondary outcomes
iHOT-12: 12-question version of the international Hip Outcome Tool
Time frame: one year
HOS: Hip Outcome Score
Time frame: one year
mHHS: Modified Harris Hip Score
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Background: PubMed 18196405Ganz R, Leunig M, Leunig-Ganz K, Harris WH. The etiology of osteoarthritis of the hip: an integrated mechanical concept. Clin Orthop Relat Res. 2008 Feb;466(2):264-72. doi: 10.1007/s11999-007-0060-z. Epub 2008 Jan 10.
- Background: PubMed 1670443Klaue K, Durnin CW, Ganz R. The acetabular rim syndrome. A clinical presentation of dysplasia of the hip. J Bone Joint Surg Br. 1991 May;73(3):423-9. doi: 10.1302/0301-620X.73B3.1670443.
- Background: PubMed 10379300Siebenrock KA, Scholl E, Lottenbach M, Ganz R. Bernese periacetabular osteotomy. Clin Orthop Relat Res. 1999 Jun;(363):9-20.
- Background: PubMed 3383491Ganz R, Klaue K, Vinh TS, Mast JW. A new periacetabular osteotomy for the treatment of hip dysplasias. Technique and preliminary results. Clin Orthop Relat Res. 1988 Jul;(232):26-36.
- Background: PubMed 18449617Steppacher SD, Tannast M, Ganz R, Siebenrock KA. Mean 20-year followup of Bernese periacetabular osteotomy. Clin Orthop Relat Res. 2008 Jul;466(7):1633-44. doi: 10.1007/s11999-008-0242-3. Epub 2008 May 1.
- Background: PubMed 22194221Kemp JL, Collins NJ, Makdissi M, Schache AG, Machotka Z, Crossley K. Hip arthroscopy for intra-articular pathology: a systematic review of outcomes with and without femoral osteoplasty. Br J Sports Med. 2012 Jul;46(9):632-43. doi: 10.1136/bjsports-2011-090428. Epub 2011 Dec 22.
- Background: PubMed 19381741Clohisy JC, Schutz AL, St John L, Schoenecker PL, Wright RW. Periacetabular osteotomy: a systematic literature review. Clin Orthop Relat Res. 2009 Aug;467(8):2041-52. doi: 10.1007/s11999-009-0842-6. Epub 2009 Apr 21.
- Background: PubMed 10379302Davey JP, Santore RF. Complications of periacetabular osteotomy. Clin Orthop Relat Res. 1999 Jun;(363):33-7.
- Background: PubMed 20660233Thawrani D, Sucato DJ, Podeszwa DA, DeLaRocha A. Complications associated with the Bernese periacetabular osteotomy for hip dysplasia in adolescents. J Bone Joint Surg Am. 2010 Jul 21;92(8):1707-14. doi: 10.2106/JBJS.I.00829.
- Background: PubMed 23054510Ginnetti JG, Pelt CE, Erickson JA, Van Dine C, Peters CL. Prevalence and treatment of intraarticular pathology recognized at the time of periacetabular osteotomy for the dysplastic hip. Clin Orthop Relat Res. 2013 Feb;471(2):498-503. doi: 10.1007/s11999-012-2602-2.
- BackgroundMuldoon MP, Santore RF. Abstract presented at Western Orthopedic Association. Adjunctive Hip Arthroscopy with Periacetabular Osteotomy for Hip Dysplasia. 2007.
- Background: PubMed 22058293Fujii M, Nakashima Y, Noguchi Y, Yamamoto T, Mawatari T, Motomura G, Iwamoto Y. Effect of intra-articular lesions on the outcome of periacetabular osteotomy in patients with symptomatic hip dysplasia. J Bone Joint Surg Br. 2011 Nov;93(11):1449-56. doi: 10.1302/0301-620X.93B11.27314.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Muldoon, MD principal investigator
Sharp HealthCare
Questions about this trial
What is this clinical trial studying?
A study testing Adjunctive hip arthroscopy to accompany PAO and PAO without adjunctive hip arthroscopy in people with Hip Dysplasia, run by Sharp HealthCare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael P Muldoon, MD (8582788300, mpmuldoon@cox.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of reoperation by final follow-up (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790749, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.