Hip OsteoarthritisHSSNCT05216666
The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty
A study testing Lateral approach and Posterior approach in people with Hip Osteoarthritis and Muscle Weakness, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hip Osteoarthritis, Muscle Weakness, Muscle Atrophy
- What is being tested?
- Lateral approach and Posterior approach
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteSweden
- Study dates
- 11 May 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty.
- Ability to understand and write swedish.
Who cannot join
- Impaired funktion of the contralateral hip or knees causing limping.
- Neuromuscular diseases
- Postoperative leg length discrepancy excceding 1 cm
- Postoperative discrepancy in femoral offset exceeding 25% of the femoral offset of the contralateral hip.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Mölndal, 431 80
Georgios Tsikandylakis, MD, PhD, +46313421000, tsikandylakis@gmail.com
About this study
Official title: Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis
Residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. The purpose of this clinical trial is to compare the risk of residual limping one year after total hip arthropasty between lateral and posterior approach.
Read the detailed description
The use of lateral approach has been empirically associated with increased risk of abductor insufficiency and limping after total hip arthroplasty compared with the posterior approach. However lateral approach remains a widespread technik because it provides a decreased risk of dislocation. In litterature, gluteus medius insufficiency has been reported even when the posterior approach has been used. In the early stage of postperative relhabilitation it is difficult to distinguish between between limping that resolves after abductor training and limping due to abductor injury/avulsion that is resistent to physiotherapy. The purpose of this randomized controlled trial is to compare the risk of persistent limping one year after total hip arthtoplasty between lateral and posterior approach and to identify patient-related risk factors for limping. Moreover it will validate ultra sound (U/S), magnetic resonance imaging (MRI) of the hip and gait analysis as diagnostic tools for early detection of limping that is going to persist one year after total hip arthroplasty.
580 patients will hip osteoarthritis be randomised to receive their total hip arthroplasty through an either lateral of posterior approach and will be followed at one year with physical examination (Trendelenburg sign) and patient.-reported outcome measures. Patients with a positive Trendelenburg sign at 3 months will undergo U/S and MRI examination as well as gait analysis and reassessed at one year with physical examination. The first 40 patients with negative Trendelenburg sign at 3 months will also undergo U/S, MRI and gait analysis. The specificity and sensitivity of U/S, MRI and gait analysis for positiv Trendelenburg sign will be calculated.
- Conditions
- Hip Osteoarthritis, Muscle Weakness, Muscle Atrophy, Muscle Injury, Arthroplasty Complications
- Being tested
- Lateral approach, Posterior approach
- Keywords
- abductor, approach, limp, Trendelenburg, gluteus medius
- Medical subject headings
- Osteoarthritis, Hip, Muscle Weakness, Muscular Atrophy, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral approachProcedure or surgery
Also called Gammer approach
Total hip arthroplasty performed through a lateral surgical approach (Gammer)
Posterior approachProcedure or surgery
Also called Moore approach
Total hip arthroplasty performed through a posterior surgical approach (Moore)
| Study group | Role | What they receive |
|---|---|---|
| Lateral approach | Active comparator | 290 participants receive their hip prosthesis through a lateral approach. The anterior third of m. gluteus medius along with the corresponding part of m. vastus lateralis are detached from the greater trochanter and the anterior capsule is excised for the exposure of the hip joint. After implant insertion, the gluteus medius is reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist. Receives: Procedure: Lateral approach |
| Posterior approach | Active comparator | 290 participants receive their hip prosthesis through a posterior approach. The m. piriformis gemelli and obturator internus are detached from the greater trochanter and the posterior capsule is incised for the exposure of the hip joint. After implant insertion, the posterior capsule as well as m piriformis and the external rotators are reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist. Receives: Procedure: Posterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trendelenburg sign as binary variable (positive/negative)
Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.
Measured: At 12 months after intervention
Secondary outcomes (15)
Dislocation
Incidens of postoperative dislocation
Measured: Within 12 months from intervention
Intraoperative blood loss
Bleeding during total hip arthroplasty measured in ml
Measured: Intraoperative
Periprosthetic infection
Incidens of deep surgical wound infection
Measured: Within 12 months from intervention
Oxford Hip Score
Patient-reported hip function measured in a scale of 0-48
Measured: At 3 months after intervention
Oxford Hip Score
Patient-reported hip function measured in a scale of 0-48
Measured: At 12 months after intervention
Euroqol 5 dimension 5 level index (EQ5D-5L)
Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1
Measured: At 3 months after intervention
Euroqol 5 dimension 5 level index (EQ5D-5L)
Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1
Measured: At 12 months after intervention
Euroqol visual analog scale (EQVAS)
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Measured: At 3 months after intervention
Euroqol visual analog scale (EQVAS)
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Measured: At 12 months after intervention
University of California Activity Level (UCLA)
Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10
Measured: At 3 months after intervention
University of California Activity Level (UCLA)
Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10
Measured: At 12 months after intervention
Gluteus medius avulsion in ultrasound
The proportion avulsed gluteus medius tendon in relation to the whole tendon attachment in a scale of 0 (no avulsion) to 1 (total avulsion). Measured with ultrasound
Measured: At 3 months after intervention
Gluteus medius atrophy in Magnetic Resonance Imaging
The area of gluteus medius muscle in the operated side divided by the area of the gluteus medius muscle in the healthy side as shown in magnetic resonance imaging in a scale of 0 (complete atrophy) to 1 (no atrophy)
Measured: At 3 months after intervention
Hip abuction torque
Hip abuction torque measured in Nm/Kg with gate analysis
Measured: At 3 months after intervention
Trendelenburg sign as binary variable (positive/negative)
Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.
Measured: At 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start11 May 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Principal investigator, Georgios Tsikandylakis, MD PhD, Sahlgrenska University Hospital
- Investigators
- Georgios Tsikandylakis, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216666
- Sponsor's protocol ID
- 277461
- Acronym
- HSS
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hailer NP, Weiss RJ, Stark A, Karrholm J. The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis. An analysis of 78,098 operations in the Swedish Hip Arthroplasty Register. Acta Orthop. 2012 Oct;83(5):442-8. doi: 10.3109/17453674.2012.733919. Epub 2012 Oct 8.
PubMed 23039167Zijlstra WP, De Hartog B, Van Steenbergen LN, Scheurs BW, Nelissen RGHH. Effect of femoral head size and surgical approach on risk of revision for dislocation after total hip arthroplasty. Acta Orthop. 2017 Aug;88(4):395-401. doi: 10.1080/17453674.2017.1317515. Epub 2017 Apr 25.
PubMed 28440704Skoogh O, Tsikandylakis G, Mohaddes M, Nemes S, Odin D, Grant P, Rolfson O. Contemporary posterior surgical approach in total hip replacement: still more reoperations due to dislocation compared with direct lateral approach? An observational study of the Swedish Hip Arthroplasty Register including 156,979 hips. Acta Orthop. 2019 Oct;90(5):411-416. doi: 10.1080/17453674.2019.1610269. Epub 2019 May 7.
PubMed 31060427Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6.
PubMed 30080985Whiteside LA, Roy ME. Incidence and treatment of abductor deficiency during total hip arthroplasty using the posterior approach: repair with direct suture technique and gluteus maximus flap transfer. Bone Joint J. 2019 Jun;101-B(6_Supple_B):116-122. doi: 10.1302/0301-620X.101B6.BJJ-2018-1511.R1.
PubMed 31146555Ewen AM, Stewart S, St Clair Gibson A, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture. 2012 May;36(1):1-6. doi: 10.1016/j.gaitpost.2011.12.024. Epub 2012 Mar 10.
PubMed 22410129
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis
- ClinicalTrials.gov ID
- NCT05216666
- Acronym / sponsor ID
- HSS / 277461
- Conditions
- Hip Osteoarthritis, Muscle Weakness, Muscle Atrophy, Muscle Injury, Arthroplasty Complications
- Keywords
- abductor, approach, limp, Trendelenburg, gluteus medius
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 11 May 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Jan 2022 (actual)
- 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.
Residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. The purpose of this clinical trial is to compare the risk of residual limping one year after total hip arthropasty between lateral and posterior approach.
Detailed description
The use of lateral approach has been empirically associated with increased risk of abductor insufficiency and limping after total hip arthroplasty compared with the posterior approach. However lateral approach remains a widespread technik because it provides a decreased risk of dislocation. In litterature, gluteus medius insufficiency has been reported even when the posterior approach has been used. In the early stage of postperative relhabilitation it is difficult to distinguish between between limping that resolves after abductor training and limping due to abductor injury/avulsion that is resistent to physiotherapy. The purpose of this randomized controlled trial is to compare the risk of persistent limping one year after total hip arthtoplasty between lateral and posterior approach and to identify patient-related risk factors for limping. Moreover it will validate ultra sound (U/S), magnetic resonance imaging (MRI) of the hip and gait analysis as diagnostic tools for early detection of limping that is going to persist one year after total hip arthroplasty.
580 patients will hip osteoarthritis be randomised to receive their total hip arthroplasty through an either lateral of posterior approach and will be followed at one year with physical examination (Trendelenburg sign) and patient.-reported outcome measures. Patients with a positive Trendelenburg sign at 3 months will undergo U/S and MRI examination as well as gait analysis and reassessed at one year with physical examination. The first 40 patients with negative Trendelenburg sign at 3 months will also undergo U/S, MRI and gait analysis. The specificity and sensitivity of U/S, MRI and gait analysis for positiv Trendelenburg sign will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Lateral approach | Active comparator | Procedure: Lateral approach290 participants receive their hip prosthesis through a lateral approach. The anterior third of m. gluteus medius along with the corresponding part of m. vastus lateralis are detached from the greater trochanter and the anterior capsule is excised for the exposure of the hip joint. After implant insertion, the gluteus medius is reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist. |
| Posterior approach | Active comparator | Procedure: Posterior approach290 participants receive their hip prosthesis through a posterior approach. The m. piriformis gemelli and obturator internus are detached from the greater trochanter and the posterior capsule is incised for the exposure of the hip joint. After implant insertion, the posterior capsule as well as m piriformis and the external rotators are reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty.
- Ability to understand and write swedish.
Key exclusion criteria (4 listed)
- Impaired funktion of the contralateral hip or knees causing limping.
- Neuromuscular diseases
- Postoperative leg length discrepancy excceding 1 cm
- Postoperative discrepancy in femoral offset exceeding 25% of the femoral offset of the contralateral hip.
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 |
|---|---|---|
| Lateral approachAlso: Gammer approachTotal hip arthroplasty performed through a lateral surgical approach (Gammer) | Procedure or surgery | Lateral approach |
| Posterior approachAlso: Moore approachTotal hip arthroplasty performed through a posterior surgical approach (Moore) | Procedure or surgery | Posterior approach |
Primary outcome
Trendelenburg sign as binary variable (positive/negative)
Time frame: At 12 months after intervention
Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.
15 secondary outcomes
Dislocation
Time frame: Within 12 months from intervention
Intraoperative blood loss
Time frame: Intraoperative
Periprosthetic infection
Time frame: Within 12 months from intervention
Oxford Hip Score
Time frame: At 3 months after intervention
Oxford Hip Score
Time frame: At 12 months after intervention
Euroqol 5 dimension 5 level index (EQ5D-5L)
Time frame: At 3 months after intervention
Euroqol 5 dimension 5 level index (EQ5D-5L)
Time frame: At 12 months after intervention
Euroqol visual analog scale (EQVAS)
Time frame: At 3 months after intervention
Euroqol visual analog scale (EQVAS)
Time frame: At 12 months after intervention
University of California Activity Level (UCLA)
Time frame: At 3 months after intervention
University of California Activity Level (UCLA)
Time frame: At 12 months after intervention
Gluteus medius avulsion in ultrasound
Time frame: At 3 months after intervention
Gluteus medius atrophy in Magnetic Resonance Imaging
Time frame: At 3 months after intervention
Hip abuction torque
Time frame: At 3 months after intervention
Trendelenburg sign as binary variable (positive/negative)
Time frame: At 3 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 23039167Hailer NP, Weiss RJ, Stark A, Karrholm J. The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis. An analysis of 78,098 operations in the Swedish Hip Arthroplasty Register. Acta Orthop. 2012 Oct;83(5):442-8. doi: 10.3109/17453674.2012.733919. Epub 2012 Oct 8.
- Background: PubMed 28440704Zijlstra WP, De Hartog B, Van Steenbergen LN, Scheurs BW, Nelissen RGHH. Effect of femoral head size and surgical approach on risk of revision for dislocation after total hip arthroplasty. Acta Orthop. 2017 Aug;88(4):395-401. doi: 10.1080/17453674.2017.1317515. Epub 2017 Apr 25.
- Background: PubMed 31060427Skoogh O, Tsikandylakis G, Mohaddes M, Nemes S, Odin D, Grant P, Rolfson O. Contemporary posterior surgical approach in total hip replacement: still more reoperations due to dislocation compared with direct lateral approach? An observational study of the Swedish Hip Arthroplasty Register including 156,979 hips. Acta Orthop. 2019 Oct;90(5):411-416. doi: 10.1080/17453674.2019.1610269. Epub 2019 May 7.
- Background: PubMed 30080985Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6.
- Background: PubMed 31146555Whiteside LA, Roy ME. Incidence and treatment of abductor deficiency during total hip arthroplasty using the posterior approach: repair with direct suture technique and gluteus maximus flap transfer. Bone Joint J. 2019 Jun;101-B(6_Supple_B):116-122. doi: 10.1302/0301-620X.101B6.BJJ-2018-1511.R1.
- Background: PubMed 22410129Ewen AM, Stewart S, St Clair Gibson A, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture. 2012 May;36(1):1-6. doi: 10.1016/j.gaitpost.2011.12.024. Epub 2012 Mar 10.
- Individual participant dataSharing planned: No
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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.
Georgios Tsikandylakis, MD PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral approach and Posterior approach in people with Hip Osteoarthritis and Muscle Weakness, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgios Tsikandylakis, MD PhD (0046313421000, tsikandylakis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trendelenburg sign as binary variable (positive/negative) (time frame: At 12 months after intervention). 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 NCT05216666, which also lists 6 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 9 Apr 2025.