Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches

NCT ID: NCT03746925

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-07

Study Completion Date

2023-04-07

Brief Summary

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This study involves comparing the outcomes after using the Direct Anterior Approach (DAA) and the Supercapsular Percutaneously Assisted Total Hip (SuperPATH) approach. These are two approaches to hip replacement that both replace hips without cutting any muscles. DAA approach has been used for many years, but it has a high learning curve and can be difficult for doctors to use, it is however linked with fewer complications when performed by an experienced doctor. SuperPATH is a newer technique which has been shown in studies to be adopted with less complications even during the learning phase. It also shows cost-saving results, showing a reduced length of stay for patients and better 30-day readmission rates. There is pressure on surgeons, from both patients and administration to use techniques that spare tissue, offer early functionality without compromising long-term outcomes. The SuperPATH can meet this benchmark but uptake has been slow, the investigators believe that it is due to the learning curve shown by this approach. The senior surgeon at The Ottawa Hospital is experienced in both techniques, using a trial the investigators can compare the two techniques and help encourage surgeons to change to a procedure that has demonstrated a low complication profile.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a 2 group, parallel study where they will be randomized into one of the two groups. One will receive SuperPATH approach and the other will receive DAA.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Direct Anterior Approach (DAA)

Direct Anterior Approach surgery to replace the hip.

Group Type ACTIVE_COMPARATOR

Direct Anterior Approach (DAA)

Intervention Type PROCEDURE

Direct Anterior Approach surgery to replace the hip.

SuperPATH

SuperPATH approach surgery to replace the hip.

Group Type EXPERIMENTAL

SuperPATH

Intervention Type PROCEDURE

SuperPATH approach surgery to replace the hip.

Interventions

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Direct Anterior Approach (DAA)

Direct Anterior Approach surgery to replace the hip.

Intervention Type PROCEDURE

SuperPATH

SuperPATH approach surgery to replace the hip.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing unilateral THA
* Over 18 years of age and below 80
* Subject is willing and able to complete required study visits and assessments
* Subject is willing to sign the approved informed consent form

Exclusion Criteria

* Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0kg/m2 and 102.0cm, respectively for men, and 35.0kg/m2 and 88.0cm, respectively for women at screening
* Subject is currently enrolled in another clinical investigation related to lower limbs, which could affect the endpoints of this protocol
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
* Subject is currently incarcerated or has impending incarceration
* Previous hip surgery or infection on ipsilateral hip
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wade Gofton, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Wade Gofton, MD, FRCSC

Role: CONTACT

613-798-5555 ext. 18779

Meaghan Dufresne

Role: CONTACT

613-737-8899

Facility Contacts

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Johanna Dobransky

Role: primary

References

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Chow J, Penenberg B, Murphy S. Modified micro-superior percutaneously-assisted total hip: early experiences & case reports. Curr Rev Musculoskelet Med. 2011 Sep;4(3):146-50. doi: 10.1007/s12178-011-9090-y.

Reference Type BACKGROUND
PMID: 21789576 (View on PubMed)

Della Torre PK, Fitch DA, Chow JC. Supercapsular percutaneously-assisted total hip arthroplasty: radiographic outcomes and surgical technique. Ann Transl Med. 2015 Aug;3(13):180. doi: 10.3978/j.issn.2305-5839.2015.08.04.

Reference Type BACKGROUND
PMID: 26366397 (View on PubMed)

Gofton W, Chow J, Olsen KD, Fitch DA. Thirty-day readmission rate and discharge status following total hip arthroplasty using the supercapsular percutaneously-assisted total hip surgical technique. Int Orthop. 2015 May;39(5):847-51. doi: 10.1007/s00264-014-2587-4. Epub 2014 Nov 16.

Reference Type BACKGROUND
PMID: 25398472 (View on PubMed)

Chow J, Fitch DA. In-hospital costs for total hip replacement performed using the supercapsular percutaneously-assisted total hip replacement surgical technique. Int Orthop. 2017 Jun;41(6):1119-1123. doi: 10.1007/s00264-016-3327-8. Epub 2016 Nov 12.

Reference Type BACKGROUND
PMID: 27838761 (View on PubMed)

SMITH-PETERSEN MN, LARSON CB, et al. Complications of old fractures of the neck of the femur; results of treatment of vitallium-mold arthroplasty. J Bone Joint Surg Am. 1947 Jan;29(1):41-8. No abstract available.

Reference Type BACKGROUND
PMID: 20284684 (View on PubMed)

Judet J, Judet H. [Anterior approach in total hip arthroplasty]. Presse Med. 1985 May 4;14(18):1031-3. French.

Reference Type BACKGROUND
PMID: 3158949 (View on PubMed)

Kennon RE, Keggi JM, Wetmore RS, Zatorski LE, Huo MH, Keggi KJ. Total hip arthroplasty through a minimally invasive anterior surgical approach. J Bone Joint Surg Am. 2003;85-A Suppl 4:39-48. doi: 10.2106/00004623-200300004-00005. No abstract available.

Reference Type BACKGROUND
PMID: 14652392 (View on PubMed)

Bal BS, Vallurupalli S. Minimally invasive total hip arthroplasty with the anterior approach. Indian J Orthop. 2008 Jul;42(3):301-8. doi: 10.4103/0019-5413.41853.

Reference Type BACKGROUND
PMID: 19753156 (View on PubMed)

Barrett WP, Turner SE, Leopold JP. Prospective randomized study of direct anterior vs postero-lateral approach for total hip arthroplasty. J Arthroplasty. 2013 Oct;28(9):1634-8. doi: 10.1016/j.arth.2013.01.034. Epub 2013 Mar 19.

Reference Type BACKGROUND
PMID: 23523485 (View on PubMed)

Goebel S, Steinert AF, Schillinger J, Eulert J, Broscheit J, Rudert M, Noth U. Reduced postoperative pain in total hip arthroplasty after minimal-invasive anterior approach. Int Orthop. 2012 Mar;36(3):491-8. doi: 10.1007/s00264-011-1280-0. Epub 2011 May 25.

Reference Type BACKGROUND
PMID: 21611823 (View on PubMed)

Alecci V, Valente M, Crucil M, Minerva M, Pellegrino CM, Sabbadini DD. Comparison of primary total hip replacements performed with a direct anterior approach versus the standard lateral approach: perioperative findings. J Orthop Traumatol. 2011 Sep;12(3):123-9. doi: 10.1007/s10195-011-0144-0. Epub 2011 Jul 12.

Reference Type BACKGROUND
PMID: 21748384 (View on PubMed)

Nakata K, Nishikawa M, Yamamoto K, Hirota S, Yoshikawa H. A clinical comparative study of the direct anterior with mini-posterior approach: two consecutive series. J Arthroplasty. 2009 Aug;24(5):698-704. doi: 10.1016/j.arth.2008.04.012. Epub 2008 Jun 13.

Reference Type BACKGROUND
PMID: 18555653 (View on PubMed)

Anterior Total Hip Arthroplasty Collaborative Investigators; Bhandari M, Matta JM, Dodgin D, Clark C, Kregor P, Bradley G, Little L. Outcomes following the single-incision anterior approach to total hip arthroplasty: a multicenter observational study. Orthop Clin North Am. 2009 Jul;40(3):329-42. doi: 10.1016/j.ocl.2009.03.001.

Reference Type BACKGROUND
PMID: 19576400 (View on PubMed)

Xie J, Zhang H, Wang L, Yao X, Pan Z, Jiang Q. Comparison of supercapsular percutaneously assisted approach total hip versus conventional posterior approach for total hip arthroplasty: a prospective, randomized controlled trial. J Orthop Surg Res. 2017 Sep 25;12(1):138. doi: 10.1186/s13018-017-0636-6.

Reference Type BACKGROUND
PMID: 28946892 (View on PubMed)

Meermans G, Konan S, Das R, Volpin A, Haddad FS. The direct anterior approach in total hip arthroplasty: a systematic review of the literature. Bone Joint J. 2017 Jun;99-B(6):732-740. doi: 10.1302/0301-620X.99B6.38053.

Reference Type BACKGROUND
PMID: 28566391 (View on PubMed)

Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials. 1988 Dec;9(4):365-74. doi: 10.1016/0197-2456(88)90049-9.

Reference Type BACKGROUND
PMID: 3203526 (View on PubMed)

Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000 Nov;27(11):2635-41.

Reference Type BACKGROUND
PMID: 11093446 (View on PubMed)

Gofton W, Fitch DA. In-hospital cost comparison between the standard lateral and supercapsular percutaneously-assisted total hip surgical techniques for total hip replacement. Int Orthop. 2016 Mar;40(3):481-5. doi: 10.1007/s00264-015-2878-4. Epub 2015 Jul 9.

Reference Type BACKGROUND
PMID: 26156723 (View on PubMed)

Varin D, Lamontagne M, Beaule PE. Does the anterior approach for THA provide closer-to-normal lower-limb motion? J Arthroplasty. 2013 Sep;28(8):1401-7. doi: 10.1016/j.arth.2012.11.018. Epub 2013 Mar 16.

Reference Type BACKGROUND
PMID: 23507070 (View on PubMed)

Kerrigan DC, Todd MK, Della Croce U. Gender differences in joint biomechanics during walking: normative study in young adults. Am J Phys Med Rehabil. 1998 Jan-Feb;77(1):2-7. doi: 10.1097/00002060-199801000-00002.

Reference Type BACKGROUND
PMID: 9482373 (View on PubMed)

Judge JO, Ounpuu S, Davis RB 3rd. Effects of age on the biomechanics and physiology of gait. Clin Geriatr Med. 1996 Nov;12(4):659-78.

Reference Type BACKGROUND
PMID: 8890109 (View on PubMed)

Other Identifiers

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SuperPATH

Identifier Type: -

Identifier Source: org_study_id

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