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Total Hip Arthroplasty (THA) is a highly effective treatment for patients with symptomatic hip osteoarthritis. The surgical approach in THA is important as it influences postoperative clinical recovery, functional outcomes, and implant positioning [1]. The evolution of surgical techniques in THA has led to the development of minimally invasive surgery, which is performed through smaller skin incisions, reduced soft tissue disruption and greater muscle preservation [2-10]. This prospective, randomised control study compares clinical and radiological outcomes in THA performed using the standard posterior approach (PA) and its less invasive modification, the direct superior approach (DSA). The study will include 80 patients with hip osteoarthritis undergoing THA. Following informed consent, patients will be randomised to one of the two treatment groups, and undergo THA using either the PA or DSA. The control group includes patients undergoing THA through the PA while the investigation group includes patients undergoing THA with the DSA. A further 25 patients randomly selected from each treatment group will undergo radiosteriometric analysis (RSA) to assess differences in early implant migration between PA and DSA groups.
Clinical and radiological outcomes of interest will be recorded by blinded observers at regular intervals for 2 years after surgery. The findings of this study will enable an improved understanding of differences in postoperative clinical recovery, functional outcomes, and implant positioning in THA performed using the DSA compared to the PA approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Superior Approach (DSA) | Experimental | Direct superior incision during surgery |
|
| Posterior Approach (PA) | Active Comparator | Posterior approach incision during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip arthroplasty | Device | Surgical intervention designed to replace arthritic joint with artificial implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain in hip at 24 hours following surgery | Pain at 24 hours following surgery as assessed using the visual analogue scale between patients undergoing PA for THA versus DSA for THA. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | Operating time in minutes | During the operation |
| Time to discharge | Time to discharge in hours | 6 weeks post operation |
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Inclusion Criteria:
Patient has hip osteoarthritis requiring primary THA
Exclusion Criteria:
Patient is not suitable for primary THA e.g. patient requires revision surgery for previously failed THA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32560737 | Derived | Kayani B, Konan S, Tahmassebi J, Ayuob A, Haddad FS. The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial. Trials. 2020 Jun 19;21(1):546. doi: 10.1186/s13063-020-04484-y. |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D017060 | Patient Satisfaction |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Analgesia requirements | Analgesia requirements | inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years. |
| Oxford Hip Score (OHS) | Patient recorded outcome measure via questionnaire. 48 is best score and 0 worst score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Hip injury and osteoarthritis outcome score (KOOS) | Patient recorded outcome measure via questionnaire. 6 separate domains including pain, stiffness, quality of life, symptoms, and function; each domain creates percentage with overall cumulative percentage achieved; best score 100% | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D) | Patient recorded outcome measure with 5 domains; score -1 to 1, with 1 being best score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Harris Hip Score [HHS] | Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Mobilisation distance | Mobilisation distance in metres | inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years. |
| Use of mobility aids | Use of mobility aids | inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years. |
| Femoral and acetabular implant early migration | Femoral and acetabular implant early migration as assessed using radiosteriometric analysis (RSA) This RSA will be performed on a cohort of 25 randomly selected patients from each treatment group. | postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years. |
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |