- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746925
Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches
August 5, 2022 updated by: Ottawa Hospital Research Institute
Randomized Control Trial Comparing Short-term Outcomes After Direct Anterior and SuperPATH Approaches
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wade Gofton, MD, FRCSC
- Phone Number: 18779 613-798-5555
- Email: wgofton@ottawahospital.on.ca
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- Recruiting
- The Ottawa Hospital
-
Contact:
- Johanna Dobransky
- Email: jdobransky@ohri.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Direct Anterior Approach (DAA)
Direct Anterior Approach surgery to replace the hip.
|
Direct Anterior Approach surgery to replace the hip.
|
Experimental: SuperPATH
SuperPATH approach surgery to replace the hip.
|
SuperPATH approach surgery to replace the hip.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
This asks the patient how their hip functions during their daily life.
It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores).
Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is.
To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Change in Gait analysis
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
This is done by a biomechanics lab for a subsection of 30 patients to test their hip movements.
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in EQ-5D-5L
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Generic health status.
Each question is scored from 1-5, with 1 being no problems and 5 being severe problems.
These scores are not aggregated.
There are 5 questions, mobility, self-care, usual activities, pain and anxiety.
The last page is asking the participant to self score their health that day out of 100.
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Change in Pre-post Hgb
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
|
Checks blood oxygen level
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
|
Change in Visual Analog Scale (VAS) Pain Score
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
|
To measure pain.
This is a line with left most end representing no pain with the rightmost representing extreme pain.
The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100.
The line is 100mm long.
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
|
Change in Complication rates
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Complications such as fractures that the participant experiences will be assessed
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Readmission rates
Time Frame: 3 months post-operatively
|
Any readmission rates for the participant
|
3 months post-operatively
|
Change in Timed-up-and-go (TUG)
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
The time it takes for the participant to get up from a chair walk 3 metres forward and back and sit back down
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Change in Timed-Stair-Climb (TSC)
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
The time it takes for a participant to go up and down a flight of 10 stairs.
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Change in Range of Motion (ROM)
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
IR and ER ROM at flexion and extension, this is measured using a goniometer (which is an instrument that measures an angle).
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Change in X-rays (AP pelvis & lateral)
Time Frame: This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
To check how their bones are faring in their hip area
|
This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Wade Gofton, MD, FRCSC, The Ottawa Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Judet J, Judet H. [Anterior approach in total hip arthroplasty]. Presse Med. 1985 May 4;14(18):1031-3. French.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2019
Primary Completion (Anticipated)
January 7, 2023
Study Completion (Anticipated)
April 7, 2023
Study Registration Dates
First Submitted
November 9, 2018
First Submitted That Met QC Criteria
November 15, 2018
First Posted (Actual)
November 20, 2018
Study Record Updates
Last Update Posted (Actual)
August 8, 2022
Last Update Submitted That Met QC Criteria
August 5, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SuperPATH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
To keep patient confidentiality safe.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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