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Two-year outcomes after arthroscopic surgery compared to physical therapy for femoracetabular impingement: A protocol for a randomized clinical trial
As the prevalence of hip pathology in the younger athletic population rises, the medical community continues to investigate effective intervention options. Femoracetabular impingement is the morphologically abnormal articulation of the femoral head against the acetabulum, and often implicated in pre...
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Published in: | BMC musculoskeletal disorders 2016-02, Vol.17 (58), p.60-60, Article 60 |
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description | As the prevalence of hip pathology in the younger athletic population rises, the medical community continues to investigate effective intervention options. Femoracetabular impingement is the morphologically abnormal articulation of the femoral head against the acetabulum, and often implicated in pre-arthritic hip conditions of musculoskeletal nature. Arthroscopic surgical decompression and non-surgical rehabilitation programs focused on strengthening and stability are common interventions. However, they have never been directly compared in clinical trials. The primary purpose of this study will be to assess the difference in outcomes between these 2 commonly utilized interventions for femoracetabular impingement.
The study will be a single site, non-inferiority, randomized controlled trial comparing two different treatment approaches (surgical and nonsurgical) for FAI. The enrollment goal is for a total of 80 subjects with a diagnosis of Femoracetabular impingement that are surgical candidates and have failed 6 weeks of conservative treatment. This will be a convenience sample of consecutive patients that are Tricare beneficiaries and seeking care at Madigan Army Medical Center. Patients that meet the criteria will be screened, provide written consent before enrollment, and then randomized into one of two arms (Group I = hip arthroscopy, Group II = physical therapy). Group I will undergo hip arthroscopy with or without labral repair. Group II will follow an impairment based physical therapy program consisting of 2 sessions per week for 6 weeks. The primary outcome will be the Hip Outcome Score and secondary measures will include the International Hip Outcome Tool and the Global Rating of Change. Measures will be taken at baseline, 6 months, 1 and 2 years. Hip-related healthcare utilization between both groups will also be assessed at the end of 2 years.
The current evidence to support both surgical and conservative interventions for femoroacetabular impingement is based on low-level research. To date, none of these interventions have been directly compared in a randomized clinical trial. Clinical trials are needed to help establish the value of these interventions in the management of femoracetabular impingement and to help define appropriate clinical pathways.
NCT01993615 30 October 2013. |
doi_str_mv | 10.1186/s12891-016-0914-1 |
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The study will be a single site, non-inferiority, randomized controlled trial comparing two different treatment approaches (surgical and nonsurgical) for FAI. The enrollment goal is for a total of 80 subjects with a diagnosis of Femoracetabular impingement that are surgical candidates and have failed 6 weeks of conservative treatment. This will be a convenience sample of consecutive patients that are Tricare beneficiaries and seeking care at Madigan Army Medical Center. Patients that meet the criteria will be screened, provide written consent before enrollment, and then randomized into one of two arms (Group I = hip arthroscopy, Group II = physical therapy). Group I will undergo hip arthroscopy with or without labral repair. Group II will follow an impairment based physical therapy program consisting of 2 sessions per week for 6 weeks. The primary outcome will be the Hip Outcome Score and secondary measures will include the International Hip Outcome Tool and the Global Rating of Change. Measures will be taken at baseline, 6 months, 1 and 2 years. Hip-related healthcare utilization between both groups will also be assessed at the end of 2 years.
The current evidence to support both surgical and conservative interventions for femoroacetabular impingement is based on low-level research. To date, none of these interventions have been directly compared in a randomized clinical trial. Clinical trials are needed to help establish the value of these interventions in the management of femoracetabular impingement and to help define appropriate clinical pathways.
NCT01993615 30 October 2013.</description><identifier>ISSN: 1471-2474</identifier><identifier>EISSN: 1471-2474</identifier><identifier>DOI: 10.1186/s12891-016-0914-1</identifier><identifier>PMID: 26846934</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adult ; Armed forces ; Arthroscopy - trends ; Bone surgery ; Care and treatment ; Clinical trials ; Complications and side effects ; Consent ; Female ; Femoracetabular Impingement - diagnosis ; Femoracetabular Impingement - therapy ; Follow-Up Studies ; Health aspects ; Humans ; Male ; Manipulative therapy ; Middle Aged ; Morphology ; Musculoskeletal diseases ; Orthopedics ; Osteoarthritis ; Pain ; Pathology ; Physical therapy ; Physical Therapy Modalities - trends ; Single-Blind Method ; Studies ; Study Protocol ; Therapeutics, Physiological ; Time Factors ; Treatment Outcome ; Young Adult</subject><ispartof>BMC musculoskeletal disorders, 2016-02, Vol.17 (58), p.60-60, Article 60</ispartof><rights>COPYRIGHT 2016 BioMed Central Ltd.</rights><rights>Copyright BioMed Central 2016</rights><rights>Mansell et al. 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c494t-5fc16bb139188fcf5f547748f723c1fae2967b6379b817dfb8bf4641412f6d2a3</citedby><cites>FETCH-LOGICAL-c494t-5fc16bb139188fcf5f547748f723c1fae2967b6379b817dfb8bf4641412f6d2a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4743428/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/1773618779?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25751,27922,27923,37010,37011,44588,53789,53791</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26846934$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mansell, Nancy S</creatorcontrib><creatorcontrib>Rhon, Daniel I</creatorcontrib><creatorcontrib>Marchant, Bryant G</creatorcontrib><creatorcontrib>Slevin, John M</creatorcontrib><creatorcontrib>Meyer, John L</creatorcontrib><title>Two-year outcomes after arthroscopic surgery compared to physical therapy for femoracetabular impingement: A protocol for a randomized clinical trial</title><title>BMC musculoskeletal disorders</title><addtitle>BMC Musculoskelet Disord</addtitle><description>As the prevalence of hip pathology in the younger athletic population rises, the medical community continues to investigate effective intervention options. Femoracetabular impingement is the morphologically abnormal articulation of the femoral head against the acetabulum, and often implicated in pre-arthritic hip conditions of musculoskeletal nature. Arthroscopic surgical decompression and non-surgical rehabilitation programs focused on strengthening and stability are common interventions. However, they have never been directly compared in clinical trials. The primary purpose of this study will be to assess the difference in outcomes between these 2 commonly utilized interventions for femoracetabular impingement.
The study will be a single site, non-inferiority, randomized controlled trial comparing two different treatment approaches (surgical and nonsurgical) for FAI. The enrollment goal is for a total of 80 subjects with a diagnosis of Femoracetabular impingement that are surgical candidates and have failed 6 weeks of conservative treatment. This will be a convenience sample of consecutive patients that are Tricare beneficiaries and seeking care at Madigan Army Medical Center. Patients that meet the criteria will be screened, provide written consent before enrollment, and then randomized into one of two arms (Group I = hip arthroscopy, Group II = physical therapy). Group I will undergo hip arthroscopy with or without labral repair. Group II will follow an impairment based physical therapy program consisting of 2 sessions per week for 6 weeks. The primary outcome will be the Hip Outcome Score and secondary measures will include the International Hip Outcome Tool and the Global Rating of Change. Measures will be taken at baseline, 6 months, 1 and 2 years. Hip-related healthcare utilization between both groups will also be assessed at the end of 2 years.
The current evidence to support both surgical and conservative interventions for femoroacetabular impingement is based on low-level research. To date, none of these interventions have been directly compared in a randomized clinical trial. Clinical trials are needed to help establish the value of these interventions in the management of femoracetabular impingement and to help define appropriate clinical pathways.
NCT01993615 30 October 2013.</description><subject>Adult</subject><subject>Armed forces</subject><subject>Arthroscopy - trends</subject><subject>Bone surgery</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Complications and side effects</subject><subject>Consent</subject><subject>Female</subject><subject>Femoracetabular Impingement - diagnosis</subject><subject>Femoracetabular Impingement - therapy</subject><subject>Follow-Up Studies</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Male</subject><subject>Manipulative therapy</subject><subject>Middle Aged</subject><subject>Morphology</subject><subject>Musculoskeletal diseases</subject><subject>Orthopedics</subject><subject>Osteoarthritis</subject><subject>Pain</subject><subject>Pathology</subject><subject>Physical therapy</subject><subject>Physical Therapy Modalities - trends</subject><subject>Single-Blind Method</subject><subject>Studies</subject><subject>Study Protocol</subject><subject>Therapeutics, Physiological</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1471-2474</issn><issn>1471-2474</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><recordid>eNptks2OFCEUhStG44yjD-DGkLhxU2NdoPhxYdKZ-JdM4mZcE4qCbiZUUQKlad_D95W2x3HGGBYQ-M6BezlN8xy6cwDBXmfAQkLbAWs7CbSFB80pUA4tppw-vLM-aZ7kfN11wAWRj5sTzARlktDT5ufV99jurU4orsXEyWakXbEJ6VR2KWYTF29QXtPWpj2qwKKTHVGJaNntszc6oLKzSS975GJCzk4xaWOLHtZQTf20-HlrJzuXN2iDlhRLNDH8ZjVKeh7j5H9UQxP8fHRLXoenzSOnQ7bPbuaz5sv7d1cXH9vLzx8-XWwuW0MlLW3vDLBhACJBCGdc73rKORWOY2LAaYsl4wMjXA4C-OgGMTjKKFDAjo1Yk7Pm7dF3WYfJjqY-M-mgluQnnfYqaq_un8x-p7bxm6o9JRSLavDqxiDFr6vNRU0-GxuCnm1cswLOsOxl39GKvvwHvY5rmmt5leKEgeBc_qW2OljlZxfrveZgqjaUEtxDL3mlzv9D1THayZs4W-fr_j0BHAWm_mlO1t3WCJ06ZEkds6RqltQhSwqq5sXd5twq_oSH_ALawceU</recordid><startdate>20160204</startdate><enddate>20160204</enddate><creator>Mansell, Nancy S</creator><creator>Rhon, Daniel I</creator><creator>Marchant, Bryant G</creator><creator>Slevin, John M</creator><creator>Meyer, John L</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QP</scope><scope>7RV</scope><scope>7TK</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20160204</creationdate><title>Two-year outcomes after arthroscopic surgery compared to physical therapy for femoracetabular impingement: A protocol for a randomized clinical trial</title><author>Mansell, Nancy S ; Rhon, Daniel I ; Marchant, Bryant G ; Slevin, John M ; Meyer, John L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c494t-5fc16bb139188fcf5f547748f723c1fae2967b6379b817dfb8bf4641412f6d2a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Armed forces</topic><topic>Arthroscopy - trends</topic><topic>Bone surgery</topic><topic>Care and treatment</topic><topic>Clinical trials</topic><topic>Complications and side effects</topic><topic>Consent</topic><topic>Female</topic><topic>Femoracetabular Impingement - diagnosis</topic><topic>Femoracetabular Impingement - therapy</topic><topic>Follow-Up Studies</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Male</topic><topic>Manipulative therapy</topic><topic>Middle Aged</topic><topic>Morphology</topic><topic>Musculoskeletal diseases</topic><topic>Orthopedics</topic><topic>Osteoarthritis</topic><topic>Pain</topic><topic>Pathology</topic><topic>Physical therapy</topic><topic>Physical Therapy Modalities - trends</topic><topic>Single-Blind Method</topic><topic>Studies</topic><topic>Study Protocol</topic><topic>Therapeutics, Physiological</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mansell, Nancy S</creatorcontrib><creatorcontrib>Rhon, Daniel I</creatorcontrib><creatorcontrib>Marchant, Bryant G</creatorcontrib><creatorcontrib>Slevin, John M</creatorcontrib><creatorcontrib>Meyer, John L</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMC musculoskeletal disorders</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mansell, Nancy S</au><au>Rhon, Daniel I</au><au>Marchant, Bryant G</au><au>Slevin, John M</au><au>Meyer, John L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Two-year outcomes after arthroscopic surgery compared to physical therapy for femoracetabular impingement: A protocol for a randomized clinical trial</atitle><jtitle>BMC musculoskeletal disorders</jtitle><addtitle>BMC Musculoskelet Disord</addtitle><date>2016-02-04</date><risdate>2016</risdate><volume>17</volume><issue>58</issue><spage>60</spage><epage>60</epage><pages>60-60</pages><artnum>60</artnum><issn>1471-2474</issn><eissn>1471-2474</eissn><abstract>As the prevalence of hip pathology in the younger athletic population rises, the medical community continues to investigate effective intervention options. Femoracetabular impingement is the morphologically abnormal articulation of the femoral head against the acetabulum, and often implicated in pre-arthritic hip conditions of musculoskeletal nature. Arthroscopic surgical decompression and non-surgical rehabilitation programs focused on strengthening and stability are common interventions. However, they have never been directly compared in clinical trials. The primary purpose of this study will be to assess the difference in outcomes between these 2 commonly utilized interventions for femoracetabular impingement.
The study will be a single site, non-inferiority, randomized controlled trial comparing two different treatment approaches (surgical and nonsurgical) for FAI. The enrollment goal is for a total of 80 subjects with a diagnosis of Femoracetabular impingement that are surgical candidates and have failed 6 weeks of conservative treatment. This will be a convenience sample of consecutive patients that are Tricare beneficiaries and seeking care at Madigan Army Medical Center. Patients that meet the criteria will be screened, provide written consent before enrollment, and then randomized into one of two arms (Group I = hip arthroscopy, Group II = physical therapy). Group I will undergo hip arthroscopy with or without labral repair. Group II will follow an impairment based physical therapy program consisting of 2 sessions per week for 6 weeks. The primary outcome will be the Hip Outcome Score and secondary measures will include the International Hip Outcome Tool and the Global Rating of Change. Measures will be taken at baseline, 6 months, 1 and 2 years. Hip-related healthcare utilization between both groups will also be assessed at the end of 2 years.
The current evidence to support both surgical and conservative interventions for femoroacetabular impingement is based on low-level research. To date, none of these interventions have been directly compared in a randomized clinical trial. Clinical trials are needed to help establish the value of these interventions in the management of femoracetabular impingement and to help define appropriate clinical pathways.
NCT01993615 30 October 2013.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>26846934</pmid><doi>10.1186/s12891-016-0914-1</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Armed forces Arthroscopy - trends Bone surgery Care and treatment Clinical trials Complications and side effects Consent Female Femoracetabular Impingement - diagnosis Femoracetabular Impingement - therapy Follow-Up Studies Health aspects Humans Male Manipulative therapy Middle Aged Morphology Musculoskeletal diseases Orthopedics Osteoarthritis Pain Pathology Physical therapy Physical Therapy Modalities - trends Single-Blind Method Studies Study Protocol Therapeutics, Physiological Time Factors Treatment Outcome Young Adult |
title | Two-year outcomes after arthroscopic surgery compared to physical therapy for femoracetabular impingement: A protocol for a randomized clinical trial |
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