Hip ArthroplastyNCT07851597
Randomized Study of Surgical Approach of Total Hip Arthroplasty (THA).
A study testing Total hip arthroplasty in people with Hip Arthroplasty, run by Uppsala University at 1 site in Sweden.
Trial summary
This study intends to analyze the healing process of the hip muscle system and to evaluate the functional recovery score after performing a cemented primary THA for osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hip Arthroplasty
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2021to 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hip osteoarthritis as indication for THA surgery
- use of cemented prosthetic Components
Who cannot join
- symptomatic osteoarthritis on the contralateral hip
- neuromuscular disorder
- dementia
- BMI>40
- previous surgery on any 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
Gävle hospital orthopaedic clinic
Gävle
Dimitrios Sotiriou, +46 26 158591, dimitrios.sotiriou@regiongavleborg.se
Dimitrios Sotiriou
About this study
Official title: Randomized Study of Surgical Approach of THA. CT/RSA, Radiography, HHS and Muscle Strength.
This study intends to analyze the healing process of the hip muscle system and to evaluate the functional recovery score after performing a cemented primary THA for osteoarthritis (OA).
Read the detailed description
This is a prospective , randomized study including 2 groups of 20 patients each. One group will be operated using a direct lateral approach and the other group will be operated using a posterolateral approach. After THA surgery, participants will be followed with plain radiography, Computed Tomography Micromotion Analysis (CTMA), clinical score and evaluation with inquiry letters. By use of CTMA, the study will analyze whether the re-attached muscle to bone is stable or not under the post-operative time period. In order to identify distinct points of measurement on skeleton, the CTMA protocol will be used to create a radiostereometric image of the bone. Muscle attachments will be marked by metal sutures visible on CT, making it feasible to measure eventual migration. The study will investigate the relationship between potential failure of muscle healing and postoperative muscle strength, pain, limping, and functional outcomes.
- Conditions
- Hip Arthroplasty
- Being tested
- Total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
Marking of surgically detached tendons with metall markers. Radiostereometric analysis of the migration of the metall markers in different time points after surgery to evaluate healing or no healing of the tendons.
| Study group | Role | What they receive |
|---|---|---|
| Direct lateral incision | Active comparator | Not described Receives: Procedure: Total hip arthroplasty |
| Posterolateral incision | Active comparator | Not described Receives: Procedure: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip abduction and external rotation strength in THA using direct lateral approach
Hip abduction and external rotation muscle strength following THA using a direct lateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the direct lateral approach, strength outcomes will be compared according to postoperative gluteus medius tendon healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.
Measured: Muscle strength preoperatively, at 3 months and 1 year after surgery.
Hip abduction and external rotation strength in THA using posterolateral approach
Hip abduction and external rotation muscle strength following THA using a posterolateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the posterolateral approach, strength outcomes will be compared according to postoperative piriformis healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.
Measured: Muscle strength preoperatively, at 3 months and 1 year after surgery.
Patient experiences based on interviews.
A qualitative content analysis will be performed to explore patients' experiences of the undergoing surgical procedure and the rehabilitation period, including thoughts, concerns, emotions, and expectations related to recovery and the social environment.
Measured: Interview 1 year after surgery.
Secondary outcomes (4)
Hip abduction and external rotation strength in THA using direct lateral or posterolateral approach
Hip abduction and external rotation muscle strength following THA using a direct lateral or a posterolateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. Strength outcomes will be compared between the two groups (direct lateral and posterolateral).
Measured: Muscle strength preoperatively, at 3 months and 1 year after surgery.
Clinical score evaluation using Harris Hip Score (HHS) inquiry.
Comparison of HHS (0-100 rating scale, where higher scores indicate less disability and better hip health) between the two surgical approach groups (direct lateral and posterolateral approach) and between subgroups defined by tendon healing status (healed vs non-healed).
Measured: HHS preoperatively, at 6 weeks and 1 year after surgery.
Presence of Trendelenburg gait on clinical examination
The presence or absence of Trendelenburg gait will be assessed by clinical examination after total hip arthroplasty. The frequency of Trendelenburg gait will be compared between the two surgical approach groups (direct lateral approach and posterior approach). Trendelenburg gait will also be compared between subgroups defined by postoperative tendon healing status (healed vs non-healed), as assessed by computed tomography motion analysis (CTMA).
Measured: Preoperatively, at 6 weeks and 1 year after surgery.
Comparison of patient health satisfaction as defined with the inquiry SF-36.
Comparison of SF-36 outcomes between the two surgical approach groups (direct lateral and posterior approach) and between subgroups defined by tendon healing status (healed vs non-healed).
Measured: SF-36 preoperatively, at 3 months and 1 year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Mar 2021
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851597
- Sponsor's protocol ID
- 2019-06188
- Other IDs
- 2019
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of concerns regarding participant privacy and confidentiality. Only aggregated study results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Surgical Approach of THA. CT/RSA, Radiography, HHS and Muscle Strength.
- ClinicalTrials.gov ID
- NCT07851597
- Acronym / sponsor ID
- 2019-06188
- Conditions
- Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Oct 2026 (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.
This study intends to analyze the healing process of the hip muscle system and to evaluate the functional recovery score after performing a cemented primary THA for osteoarthritis (OA).
Detailed description
This is a prospective , randomized study including 2 groups of 20 patients each. One group will be operated using a direct lateral approach and the other group will be operated using a posterolateral approach. After THA surgery, participants will be followed with plain radiography, Computed Tomography Micromotion Analysis (CTMA), clinical score and evaluation with inquiry letters. By use of CTMA, the study will analyze whether the re-attached muscle to bone is stable or not under the post-operative time period. In order to identify distinct points of measurement on skeleton, the CTMA protocol will be used to create a radiostereometric image of the bone. Muscle attachments will be marked by metal sutures visible on CT, making it feasible to measure eventual migration. The study will investigate the relationship between potential failure of muscle healing and postoperative muscle strength, pain, limping, and functional outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct lateral incision | Active comparator | Procedure: Total hip arthroplasty |
| Posterolateral incision | Active comparator | Procedure: Total hip arthroplasty |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hip osteoarthritis as indication for THA surgery
- use of cemented prosthetic Components
Key exclusion criteria (5 listed)
- symptomatic osteoarthritis on the contralateral hip
- neuromuscular disorder
- dementia
- BMI>40
- previous surgery on any 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 |
|---|---|---|
| Total hip arthroplastyMarking of surgically detached tendons with metall markers. Radiostereometric analysis of the migration of the metall markers in different time points after surgery to evaluate healing or no healing of the tendons. | Procedure or surgery | Direct lateral incision, Posterolateral incision |
Primary outcome
Hip abduction and external rotation strength in THA using direct lateral approach
Time frame: Muscle strength preoperatively, at 3 months and 1 year after surgery.
Hip abduction and external rotation muscle strength following THA using a direct lateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the direct lateral approach, strength outcomes will be compared according to postoperative gluteus medius tendon healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.
Hip abduction and external rotation strength in THA using posterolateral approach
Time frame: Muscle strength preoperatively, at 3 months and 1 year after surgery.
Hip abduction and external rotation muscle strength following THA using a posterolateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the posterolateral approach, strength outcomes will be compared according to postoperative piriformis healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.
Patient experiences based on interviews.
Time frame: Interview 1 year after surgery.
A qualitative content analysis will be performed to explore patients' experiences of the undergoing surgical procedure and the rehabilitation period, including thoughts, concerns, emotions, and expectations related to recovery and the social environment.
4 secondary outcomes
Hip abduction and external rotation strength in THA using direct lateral or posterolateral approach
Time frame: Muscle strength preoperatively, at 3 months and 1 year after surgery.
Clinical score evaluation using Harris Hip Score (HHS) inquiry.
Time frame: HHS preoperatively, at 6 weeks and 1 year after surgery.
Presence of Trendelenburg gait on clinical examination
Time frame: Preoperatively, at 6 weeks and 1 year after surgery.
Comparison of patient health satisfaction as defined with the inquiry SF-36.
Time frame: SF-36 preoperatively, at 3 months and 1 year after surgery.
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 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of concerns regarding participant privacy and confidentiality. Only aggregated study results will be reported.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip arthroplasty in people with Hip Arthroplasty, run by Uppsala University 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 5 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 1 Oct 2026. 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 Dimitrios Sotiriou, Medical doctor (+46762810301, dimitrios.sotiriou@regiongavleborg.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip abduction and external rotation strength in THA using direct lateral approach (time frame: Muscle strength preoperatively, at 3 months and 1 year after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.